Endotracheal tube insertion device

ABSTRACT

An intubation assembly rod is configured to have an endotracheal tube carried thereon and includes an elongated body having a distal end and a proximal end. The distal end of the intubation assembly rod body is tapered, rounded, or spherical, and defines a leading end of the intubation assembly rod. The intubation assembly rod includes a longitudinally extending channel configured such that an elongated member of a device to which the intubation assembly rod may be attached may be inserted into the channel.

BACKGROUND OF THE INVENTION

This invention relates in general to a device for introducing anintubation device, such as an endotracheal tube, into a patient. Inparticular, this invention relates to an improved endotracheal tubeinsertion device that allows the user to simultaneously open the airway,view a patient's airway, accurately position an intubation device withinthe airway, and transmit a video image of the patient's airway to theoperator and/or a medical professional located remotely from thepatient.

Tracheal intubation typically includes placing a flexible plastic tubeinto the trachea or windpipe to maintain an open airway or to serve as aconduit through which to administer certain drugs. Tracheal intubationis frequently performed in critically injured, ill, or anesthetizedpatients to facilitate ventilation of the lungs, including mechanicalventilation, and to prevent the possibility of asphyxiation or airwayobstruction. The most widely used method is orotracheal intubation, inwhich an endotracheal tube is passed through the mouth and vocal cordsinto the trachea.

Intubation is normally facilitated by using a conventional laryngoscope,a video laryngoscope, a flexible fiber-optic bronchoscope, or a flexiblevideoscope to identify the glottis and intubate the trachea of apatient, although other devices and techniques may be used. After thetrachea has been intubated, a balloon cuff is typically inflated justabove the far end of the tube to help secure the endotracheal tube inplace, to prevent leakage of respiratory gases, and to protect thetracheobronchial tree from receiving undesirable material such asstomach acid. The endotracheal tube is then secured to the patient'sface or neck and connected to a breathing device, such as a mechanicalventilator. Once there is no longer a need for ventilatory assistanceand/or protection of the airway, the endotracheal tube is removed.

Many conventional tracheal intubations involve the use of a viewinginstrument. For example, a conventional laryngoscope may consist of ahandle containing batteries that power a light, and a set ofinterchangeable rigid blades, which are either straight or curved. Thisdevice is designed to allow the laryngoscopist to directly view thelarynx.

Video laryngoscopes, flexible fiber-optic bronchoscopes, and flexiblevideoscopes have also become increasingly available. Video laryngoscopesare specialized rigid blade laryngoscopes that use a digital videocamera sensor to allow the operator to view the glottis and larynx on avideo monitor. In contrast to the conventional laryngoscope, a videolaryngoscope allows the laryngoscopist to indirectly view the larynx.This provides a significant advantage in situations where the operatorneeds to see around an acute bend in order to see the glottis, and withotherwise difficult intubation procedures. Flexible videoscopes andfiber-optic bronchoscopes are not rigid instruments, and provide an evengreater opportunity for visualizing the vocal cords due to their abilityto fully manipulate the angle and position of the camera sensor andoptics.

Successful endotracheal intubation requires adequate atraumaticlaryngeal retraction, visualization of the vocal cords, positioning ofthe endotracheal tube, and a clear passage of the endotracheal tube intothe trachea. Failure to adequately place the endotracheal tube within afew minutes often leads to permanent patient disability and even death.Currently available intubation instruments frequently lack thecapability to meet one or more of these requirements.

Visualization of the vocal cords requires retraction of the tongue andlaryngeal structures such as the epiglottis. Large tongues, excessiveoropharyngeal soft tissue, stiff and immobile necks, and unique patientanatomy can make vocal cord visualization challenging. The ability toretract and physically align the oropharyngeal and laryngeal structuresproperly for direct or camera assisted viewing with a rigid blade may bedifficult or impossible. Flexible videoscopes and fiber-opticbronchoscopes are not able to retract the tongue and laryngealstructures.

Direct rigid blade laryngoscopy allows for adequate retraction oflaryngeal structures, but is often limited in providing vocal cordvisualization in certain patient populations (e.g., thick, stiff, and/orimmobile necks) and can be traumatic when trying to improve the view bymanipulating the rigid blade between the teeth and stretching thelaryngeal tissues.

Indirect rigid blade videoscopes improve the field of vision over directrigid blades, but because the camera tip is permanently mounted on asingular site on the rigid blade, practitioners must still use rigidblade manipulation to further improve or achieve visualization of thevocal cords, often resulting in trauma as occurs with direct orallaryngoscopy. Despite manipulating the rigid blade videoscope and itsfixed camera, the angle, curvature, and depth is often limited andvisualization of the vocal cords may not be achieved.

Flexible videoscopes and fiber optic bronchoscopes provide for multipleangles and depths of view. Unfortunately, they do not provide a means toretract the tongue and laryngeal tissues that allow for visualization ofthe vocal cords. Instead, one must use a separate airway to retract thetongue and/or a second practitioner to manually retract or displace thetongue or the mandible. Although it is known to use flexible fiber-opticbronchoscopes or flexible videoscopes during intubation when the patientis under general anesthesia, the use of such devices has thedisadvantage of typically requiring two skilled individuals to intubatethe patient. It is difficult to manipulate soft tissue in the larynxwith flexible fiber-optic bronchoscopes and flexible videoscopes, anddespite these maneuvers for visualization, the passage, and the deliveryof the endotracheal tube into the trachea is often inhibited by thelaryngeal structures.

Despite proper tissue retraction and visualization of the vocal cordswith currently available instruments such as a direct laryngoscope,indirect video laryngoscope, or a flexible videoscope, the delivery,placement, and passage of the endotracheal tube is often challenging.Stiff, rigid, and potentially traumatic stylets are frequently shapedand placed within the endotracheal tube, to give more control andguidance to the endotracheal tube tip in the direction of the visualizedvocal cords. However, once the rigid stylet has been manually shaped,the user must work with that specific curvature and shape. If thecurvature and shape is not satisfactory, the user must stop thelaryngoscopy, remove all of the equipment, manually reshape the stylet,and start the procedure over from the beginning.

It is often the case with flexible videoscopes, flexible fiber-opticbronchoscopes, and rigid direct or indirect laryngoscopes, thatvisualization of the vocal cords may be achieved wherein placement ofthe endotracheal tube tip is at the vocal cords, or the flexible scopeis within the trachea, but the passage of the endotracheal tube tipthrough the larynx between the vocal cords and into the trachea isobstructed. The leading edge of the endotracheal tube tip often collideswith laryngeal structures, such as the arytenoids or the anterior wallof the trachea, preventing smooth passage of the endotracheal tube intothe trachea.

In urgent and emergency situations, especially in locations remote froma hospital, the use of flexible video laryngoscopy or fiber-opticbronchoscopy may be limited, and personnel experienced in performingdirect or indirect laryngoscopy are not always immediately available insettings that require emergency tracheal intubation.

It would therefore be desirable to provide an improved structure for adevice for introducing an endotracheal tube into a patient, wherein suchan improved device allows the user to simultaneously open the airway,view a patient's airway, accurately position an endotracheal tube orother intubation device within the airway, and if desired, transmit avideo image of the patient's airway to the operator and/or a medicalprofessional located remotely from the patient.

SUMMARY OF THE INVENTION

This invention relates to an improved structure for a device forintroducing an endotracheal tube into a patient. The improved device isconfigured to allow the user to simultaneously open the airway, view apatient's airway, accurately position an endotracheal tube or otherintubation device within the airway, and transmit a video image of thepatient's airway to the operator and/or a medical professional locatedremotely from the patient.

In one embodiment, an intubation assembly rod is configured to have anendotracheal tube carried thereon and includes an elongated body havinga distal end and a proximal end. The distal end of the intubationassembly rod body is tapered, rounded, or spherical, and defines aleading end of the intubation assembly rod. The intubation assembly rodincludes a longitudinally extending channel configured such that anelongated member of a device to which the intubation assembly rod may beattached may be inserted into the channel.

In a second embodiment, an intubation assembly rod is configured to havean endotracheal tube carried thereon and includes an elongated bodyhaving a distal end and a proximal end, and a longitudinally extendingconduit formed within the intubation assembly rod body.

In a third embodiment, an oxygen source cap is configured for use withan endotracheal tube insertion device and includes a body having acircumferentially extending wall defining a generally cylindricaloutside surface, a first end, and an open second end defining a collar.An end wall is formed at the first end and a generally cylindrical fluidinlet extends radially outward of the wall, is in fluid communicationwith the open second end, and is configured for connection to source ofoxygen. An intubation assembly rod is mounted within the body andextends to or through the end wall. The intubation assembly rod isconfigured to have an endotracheal tube carried thereon. The oxygensource cap is movably or fixedly mounted to the intubation assembly rod,and is further configured to be urged into contact with an endotrachealtube connector such that oxygen from the source of oxygen may then flowthrough the oxygen source cap into the endotracheal tube.

In a fourth embodiment, an intubation assembly rod is configured to havean endotracheal tube carried thereon and includes an elongated bodyhaving a distal end and a proximal end. A stop is attached at theproximal end of the body and is configured to retain the intubationassembly rod in a desired position within an endotracheal tube mountedon the intubation assembly rod.

Various aspects of this invention will become apparent to those skilledin the art from the following detailed description of the preferredembodiments, when read in light of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a known laryngoscope.

FIG. 2 is a perspective view of an embodiment of a known endotrachealtube insertion device.

FIG. 3 is a bottom plan view of a portion of the endotracheal tubeinsertion device illustrated in FIG. 2.

FIG. 4 is a perspective view of the blade assembly illustrated in FIGS.2 and 3.

FIG. 5 is a perspective view of the optical assembly illustrated inFIGS. 2 and 3.

FIG. 6 is a perspective view of the optical assembly illustrated in FIG.5 showing the optical housing removed.

FIG. 7 is an alternate perspective view of the optical assemblyillustrated in FIG. 6.

FIG. 7A is a cross-sectional view taken along the line 7A-7A of FIG. 7.

FIG. 8 is an exploded perspective view of the intubation assembly rodillustrated in FIGS. 2 and 3.

FIG. 8A is a cross-sectional view taken along the line 8A-8A of FIG. 8.

FIG. 8B is an enlarged perspective view of a first embodiment of thefirst connecting member illustrated in FIG. 8.

FIG. 8C is an elevational view of an alternate embodiment of the firstconnecting member illustrated in FIGS. 8 and 8A.

FIG. 8D is an enlarged perspective view of a second embodiment of thefirst connecting member illustrated in FIG. 8.

FIG. 9 is a perspective view of the conventional endotracheal tubeillustrated in FIGS. 2 and 3.

FIG. 10 is a plan view of a second embodiment of the intubation assemblyrod illustrated in FIG. 8.

FIG. 11 is a perspective view of a second embodiment of the bladeassembly illustrated in FIG. 4.

FIG. 12 is a perspective view of a third embodiment of the intubationassembly rod illustrated in FIG. 8.

FIG. 12A is an end view of the third embodiment of the intubationassembly rod illustrated in FIG. 12.

FIG. 13 is a perspective view of a fourth embodiment of the intubationassembly rod illustrated in FIG. 8.

FIG. 14 is a perspective view of a fifth embodiment of the intubationassembly rod illustrated in FIG. 8.

FIG. 14A is an end view of the fifth embodiment of the intubationassembly rod illustrated in FIG. 14 showing a first embodiment of thesleeve and a stop member.

FIG. 14B is an end view of the fifth embodiment of the intubationassembly rod illustrated in FIG. 14 showing a second embodiment of thesleeve and a stop member.

FIG. 15 is a plan view of a sixth embodiment of the intubation assemblyrod illustrated in FIG. 8.

FIG. 16 is an elevational view of a portion of a second embodiment of aknown endotracheal tube insertion device.

FIG. 17 is a perspective view of the second embodiment of theendotracheal tube insertion device illustrated in FIG. 16.

FIG. 18 is a cross-sectional view taken along the line 18-18 of FIG. 17.

FIG. 19 is a cross-sectional view of a portion of the optical assemblyillustrated in FIGS. 2 and 3 showing the intubation assembly rod mountedtherein.

FIG. 20 is a perspective view of a third embodiment of a knownendotracheal tube insertion device.

FIG. 21 is an enlarged perspective view of a portion of the thirdembodiment of the endotracheal tube insertion device illustrated in FIG.20.

FIG. 22 is a perspective view of a portion of a second embodiment of theflexible member illustrated in FIG. 2.

FIG. 23 is a perspective view of a portion of a third embodiment of theflexible member illustrated in FIG. 2.

FIG. 24 is a perspective view of a portion of a fourth embodiment of theflexible member illustrated in FIG. 2.

FIG. 25 is a perspective view of a portion of a fifth embodiment of theflexible member illustrated in FIG. 2.

FIG. 26 is a perspective view of a portion of a sixth embodiment of theflexible member illustrated in FIG. 2.

FIG. 27 is a perspective view of a portion of a seventh embodiment ofthe intubation assembly rod illustrated in FIG. 8.

FIG. 28 is a perspective view of a portion of an eighth embodiment ofthe intubation assembly rod illustrated in FIG. 8.

FIG. 29 is a perspective view of a portion of a ninth embodiment of theintubation assembly rod illustrated in FIG. 8.

FIG. 30A is a perspective view of a portion of a tenth embodiment of theintubation assembly rod illustrated in FIG. 8.

FIG. 30B is a perspective view of a portion of an eleventh embodiment ofthe intubation assembly rod illustrated in FIGS. 8 and 30A.

FIG. 31 is an end view of a second embodiment of the channel memberillustrated in FIG. 2.

FIG. 32 is a perspective view of the second embodiment of the channelmember illustrated in FIG. 31.

FIG. 33 is a perspective view of a portion of a seventh embodiment ofthe flexible member illustrated in FIG. 2.

FIG. 34 is a cross-sectional view taken along the line 34-34 of FIG. 33.

FIG. 35 is a cross-sectional view taken along the line 35-35 of FIG. 33.

FIG. 36 is a perspective view of an alternate embodiment of theintubation assembly rod illustrated in FIG. 8 having a ball-shaped tipand shown prior to installation on the flexible member illustrated inFIG. 24.

FIG. 37 is a perspective view of the intubation assembly rod and theflexible member illustrated in FIG. 36 shown assembled.

FIG. 38 is a plan view of a portion of a twelfth embodiment of theintubation assembly rod illustrated in FIG. 8.

FIG. 39 is a plan view of a portion of a thirteenth embodiment of theintubation assembly rod illustrated in FIG. 8.

FIG. 40 is a plan view of a portion of a fourteenth embodiment of theintubation assembly rod illustrated in FIG. 8.

FIG. 41 is a perspective view of a fourth embodiment of the improvedendotracheal tube insertion device in accordance with this invention.

FIG. 42 is a top view of a portion of the flexible member illustrated inFIG. 22 and a fifteenth embodiment of the intubation assembly rod.

FIG. 43 is a side view of the portion of the flexible member and theintubation assembly rod illustrated in FIGS. 22 and 42.

FIG. 44 is an end view of the portion of the flexible member and theintubation assembly rod illustrated in FIGS. 22, 42, and 43.

FIG. 45 is a cross-sectional view of the optical assembly illustrated inFIG. 18 showing an alternate embodiment of the optical housing.

FIG. 46 is an end view of a third embodiment of the blade assemblyaccording to the invention.

FIG. 47 is a schematic side elevational view of a portion of anendotracheal tube insertion device showing an alternative embodiment ofa blade body.

FIG. 48 is a perspective view of a portion of an alternate embodiment ofa flexible member according to this invention.

FIG. 49 is a perspective view of a first embodiment of an oxygen sourcecap according to this invention shown mounted on a flexible member.

FIG. 50 is a top plan view of a first embodiment of a handle and bladeassembly according to this invention.

FIG. 51 is a top plan view of a second embodiment of the handle andblade assembly illustrated in FIG. 50.

FIG. 52 is an enlarged top plan view of an alternative embodiment of ablade assembly according to this invention.

FIG. 53 is a perspective view of a sixteenth embodiment of theintubation assembly rod shown inserted in a conventional endotrachealtube and a conventional endotracheal tube connector.

FIG. 54 is a perspective view of a seventeenth embodiment of theintubation assembly rod shown inserted in a conventional endotrachealtube connector and having a second embodiment of the oxygen source capmounted thereon.

FIG. 55 is a top plan view of a third embodiment of a handle and bladeassembly according to this invention.

FIG. 56 is a side elevational view of the handle and blade assemblyillustrated in FIG. 55.

FIG. 57 is a side elevational view of a portion of an eighteenthembodiment of the intubation assembly rod.

FIG. 58 is a side elevational view of a portion of a nineteenthembodiment of the intubation assembly rod.

FIG. 59 is a perspective view of a third embodiment of the oxygen sourcecap mounted shown with an intubation assembly rod.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention will now be described with occasional reference tothe specific embodiments of the invention. This invention may, however,be embodied in different forms and should not be construed as limited tothe embodiments set forth herein. Rather, these embodiments are providedso that this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art.

Referring now to the drawings, an embodiment of a known laryngoscope isindicated generally at 10 in FIG. 1. The illustrated laryngoscope 10 isdescribed in detail in U.S. Pat. No. 7,563,227 to Gardner, thedisclosure of which in incorporated herein in its entirety.

As shown in FIG. 1, the laryngoscope 10 includes a handle 12 and aviewing member 14. The viewing member 14 is made so that it cantelescope between a first extended position and a second contractedposition. A telescoping portion 14 a is attached at a hinge 16 to ablade portion 17 having a blade 18. The viewing member 14 is configuredsuch that it can be moved to first folded position parallel to thehandle 12, as illustrated by phantom lines in FIG. 1.

The laryngoscope 10 also includes a flexible tubular member 20 adjacentto the blade 18. An eyepiece 22 and a ratcheting member 24 areoperationally attached to the flexible tubular member 20. A generallyC-shaped rigid channel 17 c is provided on an underside of the blade 18and is configured to hold the flexible tubular member 20 and to act as aguide for the flexible tubular member 20 when it is advanced. Theflexible tube member 20 is configured such that it can be advancedforward (to the right when viewing FIG. 1) through the channel 17 c sothat a tip 20 t of the flexible tube member 20 is distal of the end ofthe blade 18, to provide a better view of the patient's anatomy.

The flexible tube member 20 includes a plurality of longitudinallyextending channels (not shown in FIG. 1). The channels may be configuredfor a variety of uses, including as a suction tube, or within whichimplements such as a fiber optic scope, illumination means, or aguidewire 26 may be mounted. The guidewire 26 is configured to beinserted through a conventional endotracheal tube, not shown in FIG. 1.The suction tube may be attached to a vacuum port 28, which may befurther connected to a source of suction (not shown) external to thelaryngoscope 10.

FIGS. 2 through 15 illustrate portions of an improved endotracheal tubeinsertion device, indicated generally at 30. The improved endotrachealtube insertion device 30 is an improved device for introducing anintubation device, such as a conventional endotracheal tube 92, shown inFIG. 9, into a patient. The improved endotracheal tube insertion device30 is configured to allow the user to simultaneously open the airway,view a patient's airway, accurately position the endotracheal tube 92within the airway, and transmit a video image of the patient's airway.

The improved endotracheal tube insertion device 30 includes a handle 32attached to a blade assembly 34, an optical assembly 36, and a guidedintroducer intubation assembly 38. In the embodiment illustrated inFIGS. 2 and 3, the handle 32 is configured to be gripped by the hand ofthe user of the endotracheal tube insertion device 30.

A video monitor 40 is attached to a proximal end of the optical assembly36 and is operationally connected to a video imaging device 60, shown inFIG. 7 and described below, within the optical assembly 36. In theillustrated embodiment, the video monitor 40 is mounted to a flexibleoptical assembly member or flexible member 52, described in detailbelow, such that it is movable or adjustable to any desired angle forease in viewing. The video monitor 40 may also be releasably attached tothe optical assembly 36 for remote viewing at a distance from thepatient. Further, one or more additional video monitors 40 (not shown)may be positioned remotely from the endotracheal tube insertion device30 and connected thereto by a wired or a wireless connection.Alternatively, the video monitor 40 may also be attached, includingreleasably attached, to the handle 32. In the illustrated embodiment,the video monitor has a substantially rectangular shape. Alternatively,the video monitor 40 may have any desired shape and size.

The handle 32 may also include a processor or controller 33 with Wi-Fi,or local area wireless technology that allows the endotracheal tubeinsertion device 30 to participate in computer networking. The processoror controller 33 may also have Bluetooth capability to allow a medicalspecialist to view, via the internet, any video images captured by theoptical assembly 36. If desired, the controller 33 may be provided as apart of the video monitor 40, or at any other desired location in theimproved endotracheal tube insertion device 30. Alternatively, in lieuof the handle 32, the handle and viewing member described in U.S. Pat.No. 7,563,227 may be provided.

The blade assembly 34 has an insertion member configured as an elongatedblade body 35 attached to a channel member 37, as best shown in FIGS. 3and 4. The elongated blade body 35 includes a first or distal end 35 a,a second or proximal end 35 b attached to the handle 32. As shown inFIGS. 3 and 4, the blade body 35 is substantially straight in thelongitudinal direction and has an arcuate cross-sectional shape.

The channel member 37 includes a first or distal end 37 a, and a secondor proximal end 37 b, defines a longitudinally extending channel 37 c,and is attached to a first side 35 c (lower side when viewing FIGS. 2and 4) of the blade body 35. As also shown in FIG. 4, the channel member37 is substantially C-shaped when viewed in cross-section and defines anelongated slot 37 b that provides access to the channel 37 c.Alternatively, the channel member 37 may have any desiredcross-sectional shape, such as substantially oval, and substantiallyrectangular.

When viewed from the bottom of the blade body 35, as shown in FIG. 3,the channel 37 c of the channel member 37 opens toward a first edge 35 e1 of the blade body 35 (the upper edge when viewing FIG. 3).Alternatively, the channel 37 c of the channel member 37 may open in anydesired direction, such as toward a second edge 35 e 2 of the blade body35 (the lower edge when viewing FIG. 3). As also shown in FIG. 3, thechannel member 37 is positioned near the first edge 35 e 1 of the bladebody 35 (the upper edge when viewing FIG. 3). Alternatively, the channelmember 37 may be positioned near the second edge 35 e 2 of the bladebody 35 (the lower edge when viewing FIG. 3), or at any positionintermediate the first edge 35 e 1 and the second edge 35 e 2.

The blade body 35 may have any desired length, such as a length withinthe range of from about 8 cm to about 20 cm. Alternatively, the bladebody 35 may be shorter than about 8 cm or longer than about 20 cm. Theblade body 35 and the channel member 37 may be formed from any desiredrigid or semi-rigid material, such as stainless steel and polyvinylchloride (PVC). In the illustrated embodiment, the distal end 37 a ofthe channel member 37 is spaced a short distance apart from the distalend 35 a of the blade body 35, and the proximal end 37 b of the channelmember 37 terminates at the proximal end of the 35 b of the blade body.The distal end 37 a of the channel member 37 may be positioned at anydesired distance from the distal end 35 a of the blade body 35. Ifdesired, the proximal end 37 b of the channel member 37 may terminateprior to the proximal end of the 35 b of the blade body (to the right ofthe proximal end of the 35 b of the blade body when viewing FIG. 3) ormay extend beyond the proximal end of the 35 b of the blade body (to theleft of the proximal end of the 35 b of the blade body when viewing FIG.3). The illustrated blade assembly 34 includes the substantiallystraight blade body 35. Alternatively, the blade assembly 34 may beformed with the curved blade body 44, described in detail below.

If desired, endotracheal tube retention tabs may be provided on theblade assembly 34 of the endotracheal tube insertion device 30. Forexample, as shown in FIG. 2, two endotracheal tube retention tabs 39 aextend outwardly and upwardly (when viewing FIG. 2) from the channelmember 37 and one endotracheal tube retention tab 39 b extends outwardlyand downwardly (when viewing FIG. 2) from the handle 32. Theendotracheal tube retention tabs 39 a and 39 b have a generally arcuateshape and are configured to allow the endotracheal tube 92 to betemporarily positioned and retained between the endotracheal tuberetention tabs 39 a and the endotracheal tube retention tab 39 b.Alternatively, the tracheal tube retention tabs 39 a and 39 b may haveany other desired shape suitable for retaining the endotracheal tube 92.Like the blade body 35 and the channel member 37, the endotracheal tuberetention tabs 39 a and 39 b may be formed from any desired rigid orsemi-rigid material, such as stainless steel and polyvinyl chloride(PVC). It will be understood that any desired number of endotrachealtube retention tabs 39 a and 39 b may be provided. Further, theendotracheal tube retention tabs 39 a and 39 b may be provided at anydesired location on the blade assembly 34 and/or the handle 32.

Referring to FIG. 11, a second embodiment of the blade assembly is shownat 42 attached to the handle 32. The blade assembly 42 has an elongatedand upwardly curved blade body 44 attached to a channel member 46. Theblade body 44 includes a first or distal end 44 a, and a second orproximal end 44 b attached to the handle 32. Like the blade body 35, theblade body 44 has an arcuate cross-sectional shape.

The channel member 46 is attached to a first side 44 c (lower side whenviewing FIG. 11) of the blade body 44, includes a first portion 46 a anda second portion 46 b, and defines a longitudinally extending channel 46c. The channel member 46 is substantially C-shaped when viewed incross-section and defines an elongated slot 46 d that provides access tothe channel 46 c. Alternatively, the channel member 46 may have anydesired cross-sectional shape, such as substantially oval, andsubstantially rectangular. The second portion 46 b of the channel member46 extends beyond the proximal end 44 b of the blade body 44 any desireddistance, and includes a plurality of notches 48 formed in at least oneside of the elongated slot 46 d. A distal end of the first portion 46 aof the channel member 46 may be positioned at any desired distance fromthe distal end 44 a of the blade body 44. Like the channel 37 c of thechannel member 37, the channel 46 c of the channel member 46 may open inany desired direction relative to the blade body 44, and may belaterally positioned near either longitudinal edge of the blade body 44,or any position intermediate thereof. The illustrated blade assembly 42includes the curved blade body 44. Alternatively, the blade assembly 42may be formed with the substantially straight blade body 35, describedin detail above.

If desired, endotracheal tube retention tabs may also be provided on theblade assembly 42. For example, as shown in FIG. 11, two endotrachealtube retention tabs 49 a extend outwardly and upwardly (when viewingFIG. 11) from the channel member 46 and one endotracheal tube retentiontab 49 b extends outwardly and downwardly (when viewing FIG. 11) fromthe handle 32. The endotracheal tube retention tabs 49 a and 49 b have agenerally arcuate shape and are configured to allow the endotrachealtube 92 to be temporarily positioned and retained between theendotracheal tube retention tabs 49 a and the endotracheal tuberetention tab 49 b. Alternatively, the endotracheal tube retention tabs49 a and 49 b may have any other desired shape suitable for retainingthe endotracheal tube 92. Like the endotracheal tube retention tabs 39 aand 39 b, the endotracheal tube retention tabs 49 a and 49 b may beformed from any desired rigid or semi-rigid material, such as stainlesssteel and polyvinyl chloride (PVC). It will be understood that anydesired number of endotracheal tube retention tabs 49 a and 49 b may beprovided. Further, the endotracheal tube retention tabs 49 a and 49 bmay be provided at any desired location on the blade assembly 42 and/orthe handle 32.

As shown in FIG. 2, the optical assembly 36 is disposed within thechannel 37 c of the channel member 37. As best shown in FIGS. 5 through7, the optical assembly 36 includes an optical housing 50 and theflexible member 52. The illustrated optical housing 50 includes a firstportion 50 a and a second portion 50 b, and defines a longitudinallyextending channel 50 c. The optical housing 50 is substantially circularwhen viewed in cross-section and defines an elongated slot 50 d thatprovides access to the channel 50 c. Alternatively, the optical housing50 may have any desired cross-sectional shape, such as substantiallyoval. In the illustrated embodiment of the optical housing 50, an insidediameter of the second portion 50 b of the optical housing 50 is largerthan an inside diameter of the first portion 50 a. Alternatively, theinside diameter of the second portion 50 b may be smaller than or equalto the inside diameter of the first portion 50 a. The second portionalso includes a plurality of the notches 48 formed in at least one sideof the elongated slot 50 d. The optical housing 50 may be formed fromany desired rigid or semi-rigid material, such as PVC, wire-reinforcedsilicon, and stainless steel. Additionally, the optical housing 50 maybe configured to be relatively more flexible at a portion of the opticalhousing 50 between the first and second portions 50 a and 50 b, thusallowing the user to bend the portion of the optical housing 50 thatextends between the channel member 37 and the video monitor 40, as shownin FIG. 2.

Although the blade assembly 34 of the illustrated improved endotrachealtube insertion device 30 is shown having the channel member 37 attachedthereto, the channel member 37 is not required. For example, the firstportion 50 a of the optical housing 50 illustrated in FIG. 5 may beattached to the first side 35 c (lower side when viewing FIGS. 2 and 4)of the blade body 35 in the same manner that the channel member 37 isattached. In such an embodiment, the longitudinally extending channel 50c would function in the same manner as the longitudinally extendingchannel 37 c of the channel member 37.

As best shown in FIGS. 6 and 7, the flexible member 52 is an elongatedmember having an axis A1, a substantially cylindrical shape and includesa first or distal end 52 a and a second or proximal end 52 b.Alternatively, the flexible member 52 may have any other desiredcross-sectional shape, such as substantially oval, substantiallyhexagonal, and substantially rectangular. A plurality of longitudinallyextending conduits is formed within the flexible member 52. As shown inFIG. 7, the flexible member 52 includes a first longitudinally extendingconduit 54, a second longitudinally extending conduit 56, and a thirdlongitudinally extending conduit 58. The video imaging device 60 isdisposed in the first longitudinally extending conduit 54. In theillustrated embodiment, the video imaging device 60 is a ComplementaryMetal Oxide Silicon (CMOS) camera. Alternatively, the video imagingdevice 60 may be any desired video imaging device, such as aCharge-Coupled Device (CCD), fiber optic camera, and any other direct orindirect imaging device.

A light source 62 is disposed in the second longitudinally extendingconduit 56. In the illustrated embodiment, the light source 62 is an LEDlamp or an incandescent bulb mounted at the distal end 52 a of theflexible member 52. Alternatively, the light source 62 may be any othersource of light. Additionally, the light source 62 may be a fiber opticcable connected at its proximal end to a source of illumination (notshown), such as an LED lamp, an incandescent bulb, or any other desiredlight source. The video imaging device 60 and the light source 62 areoperationally connected to the video monitor 40 and/or the controller 33by one or more flexible electrical and/or optical connectors, shown at66 in FIG. 6.

The third longitudinally extending conduit 58 is configured as a suctiontube and is connected to a vacuum port, such as a vacuum port 59extending outward of the knob 68 a, as shown in FIG. 5. Althoughdescribed as a suction tube, the conduit 58 may also be used to provideoxygen to a patient. The conduit 58 may further be used to introducetools, such as medical instruments (not shown) into the patient. In theillustrated embodiment, the flexible member 52 has an outside diameterof about 4 mm. Alternatively, the flexible member 52 may have any otheroutside diameter.

The distal end 52 a of the flexible member 52 also includes anintubation assembly guide channel 64, the purpose for which will bedescribed below. The illustrated intubation assembly guide channel 64includes a first portion 64 a, a second portion 64 b proximal of thefirst portion 64 a, and a third portion 64 c adjacent to, and radiallyinward of, the second portion 64 b, as shown in FIG. 7A. In theillustrated embodiment, the third portion 64 c is wider than the secondportion 64 b for reasons that will be described below. Specifically, thethird portion 64 c is substantially cylindrical and has an insidediameter about the same size at an outside diameter of an elongatedguide member portion 78 of a guide rail 75, described below.Alternatively, the third portion 64 c may have any other desiredcross-sectional shape, such as substantially oval, substantiallyhexagonal, and substantially rectangular. If desired, the third portion64 c may have any desired inside diameter, such as an inside diameterlarger than the outside diameter of the guide member portion 78 of theguide rail 75. Additionally, the first portion 64 a has a relativelywide longitudinal opening and the second portion 64 b has a longitudinalopening smaller than the longitudinal opening of the first portion 64 a.

In the illustrated embodiment, the intubation assembly guide channel 64has a length within the range of about 3 cm to about 7 cm, the firstportion 64 a has a length within the range of about 0.5 cm to about 2cm, and the second and third portions 64 b and 64 c have a length withinthe range of about 2 cm to about 5 cm. Alternately, the intubationassembly guide channel 64, and each of the first, second, and thirdportions 64 a, 64 b, and 64 c may have any desired length and width.

Further, it will be understood that the flexible member 52 maybe formedwithout the relatively wide first channel portion 64 a, and with onlythe second and third portions 64 b and 64 c, such as shown in FIG. 7A.In an embodiment of the flexible member 52 having only the second andthird portions 64 b and 64 c of the intubation assembly guide channel64, each of the second and third portions 64 b and 64 c may have anydesired length, such as a length within the range of about 2 cm to about7 cm.

In the illustrated embodiment, the first and second longitudinallyextending conduits 54 and 56 have a circular cross sectional shape, andthe third longitudinally extending conduit 58 has an oval crosssectional shape. Alternatively, the first, second, and thirdlongitudinally extending conduits 54, 56, and 58 may have any desiredcross sectional shape. The flexible member 52 may be formed from anydesired flexible or semi-flexible material, such as silicon, rubber,wire-reinforced silicon, wire-reinforced rubber, and polymers.Additionally, the flexible member 52 may be configured to be relativelymore flexible at its distal end 52 a and relatively less flexible at itsproximal end 52 b, thus providing greater flexibility within a patient'sairway, and less flexibility, and therefore greater control, for theuser when handling the proximal end 52 b.

The distal end 52 a of the flexible member 52 also includes a mechanism(not shown) for moving a portion of the distal end 52 a, so as to viewdesired portions of the patient's air passage. The mechanism (not shown)defines a joint J, may be mechanically or electrically actuated, and isconfigured to move the distal end 52 a through an angle B1. In theillustrated embodiment, the angle B1 is about +/−90 degrees from theaxis A1 of the flexible member 52. Additionally, the distal end 52 a ofthe flexible member 52 may be articulating so as to be configured tomove in any radial direction, thus the joint J may be configured as anarticulating joint.

The mechanism for moving a portion of the distal end 52 a may becontrolled by a control device 68 at the proximal end 52 b of theflexible member 52. The illustrated control device 68 includes therotatable knob 68 a and a mounting post 68 b. Alternatively, the controldevice 68 may located at any other desired location on the flexiblemember 52 or any other desired location on the improved endotrachealtube insertion device 30. The mechanism for moving a portion of thedistal end 52 a, and therefore the movement of the distal end 52 a ofthe flexible member 52, may be controlled by the control device 68, thusallowing the user to move the distal end 52 a of the flexible member 52to a desired location and to lock or retain the distal end 52 a in theposition selected by the user. As shown in FIGS. 5 through 7, anattachment member 70 is attached to the mounting post 68 b of thecontrol device 68. The attachment member 70 may be any device configuredto retain the guided introducer intubation assembly 38 and its attachedendotracheal tube 92, described below, relative to the improvedendotracheal tube insertion device 30, and more specifically relative tothe flexible member 52. Alternatively, the attachment member 70 may bemounted to any desired portion of the improved endotracheal tubeinsertion device 30, including the handle 32 and the video monitor 40.

The guided introducer intubation assembly 38 includes an intubationassembly body configured as a rod 72, best shown in FIGS. 8 and 8A,which defines an introducer or bougie. The rod 72 is substantiallycylindrical and has an elongated body having a first or distal end 72 aand a second or proximal end 72 b. Alternatively, the rod 72 may haveany other desired cross-sectional shape, such as substantially oval,substantially hexagonal, and substantially rectangular. The distal end72 a of the rod 72 is tapered or substantially cone-shaped and defines aleading end of the rod 72. The rod 72 includes a plurality oflongitudinally and radially outwardly extending ribs 74. In theillustrated embodiment, the rod 72 is shown prior to being inserted intothe endotracheal tube 92, such as the endotracheal tube 92 shown in FIG.9. As shown, the ribs 74 have an arcuate cross-sectional shape. The ribs74 may extend for any desired length of the rod 72 and taper toward thedistal end 72 a.

The illustrated rod 72 includes a guide system configured to guide theendotracheal tube 92 into the trachea, and configured for releasableattachment to the flexible member 52 of the optical assembly 36. In theillustrated embodiment, the guide system is a guide rail 75. Theillustrated guide rail 75 includes a substantially spherical tip 76 at adistal end of the guide member portion 78. The guide member portion 78may be attached to the rod 72 by a substantially flat bridge 80 thatextends between the rod 72 and the guide member portion 78.Alternatively, the guide member portion 78 may be attached directly tothe rod 72 without the bridge 80. Although illustrated as spherical, thetip 76 may have other shapes, such as substantially ovoid, or having theshape of a rectangular prism or a triangular prism. It will beunderstood that the tip 76 is not required, and the distal end of theguide member portion 78 may have a rounded or tapered surface.Additionally, the tip 76 may be of any size and have any shape that fitswithin the first portion 64 a. Further, the guide member portion 78 isconfigured to fit within the third portion 64 c, and has a diameterlarge enough that it is laterally retained, i.e., that it cannot fall orbe otherwise laterally removed through the second portion 64 b of theguide channel 64. In the illustrated embodiment, the guided introducerintubation assembly 38 has an overall length within the range of about40 cm to about 50 cm. Alternatively, the guided introducer intubationassembly 38 may have any other desired length.

As best shown in FIG. 8, the guide member portion 78 has a substantiallycylindrical shape and a length L1, measured from the spherical tip 76,of about 5 cm. Alternatively, the guide member portion 78 may have anyother desired cross-sectional shape, such as substantially oval,substantially hexagonal, and substantially rectangular. Further, theguide member portion 78 may have any desired length L1, such as a lengthfrom about 4 cm to about 6 cm. The illustrated bridge 80 extends from apoint near the spherical tip 76 to a point near a proximal end of theguide member portion 78. The bridge 80 may have any width and length,and may be attached to the guide member portion 78 at any point proximalto the spherical tip 76 or proximal to a distal end of the guide memberportion 78 if the guide member portion 78 is formed without the tip 76.Alternatively, the bridge 80 may be located at any desired portion ofthe rod 72. The substantially cylindrically shaped portion of the rod 72thus begins at a point about 7 cm from the spherical tip 76.Alternatively, the substantially cylindrically shaped portion of the rod72 may begin at any desired distance from the spherical tip 76, such asa distance from about 6 cm to about 8 cm. The bridge 80 may have anydesired thickness such that the bridge 80 may extend through the secondportion 64 b of the guide channel 64, as described in detail below.

The rod 72 and the ribs 74 formed thereon, and the guide rail 75 and itscomponent parts; i.e., the guide member portion 78, the substantiallyspherical tip 76, and the bridge 80, may be formed from any flexible orsemi-flexible material, such as silicon, rubber, wire-reinforcedsilicon, wire-reinforced rubber, and polymers. Additionally, the rod 72may be configured to be relatively more flexible at its distal end 72 aand relatively less flexible at its proximal end 72 b, thus providinggreater flexibility within a patient's airway, and less flexibility, andtherefore greater control, for the user when handling the proximal end72 b.

If desired, in lieu of the ribs 74, the ribbed portion of the rod 72 maybe configured to include a solid, an expandable, or a hollow inflatableportion, a leading edge of which may be formed with a tapered orsubstantially frusto-conical shaped transition segment where the ribs 74would otherwise begin. This solid, expandable, or inflatable portion ofthe rod 72 may have, or may be inflated to have a desired outsidediameter corresponding to inside diameter of an endotracheal tube 92.

Alternatively, the improved endotracheal tube insertion device 30 may beprovided with a plurality of rods 72, each with ribs 74 having adifferent outside diameter corresponding to the inside diameter of oneof a plurality of endotracheal tubes 92 having different insidediameters. Additionally, the improved endotracheal tube insertion device30 may be provided with a plurality of rods 72 formed without ribs, eachof the plurality of rods having a different outside diametercorresponding to the inside diameter of one of a plurality ofendotracheal tubes 92 having different inside diameters. It will beunderstood that each embodiment of the rod described herein, includingthe embodiment of the rod having the hollow inflatable member describedabove, may be formed with the tapered or substantially cone-shapedleading end as described above and illustrated, for example, at 72 a inFIG. 8.

The flexible or semi-flexible material and arcuate cross-sectional shapeof the ribs 74 allow the ribs to be generally flexible; i.e., radiallycompressible such that the outside diameter of the ribs may vary andsuch that the rod 72 may be used in endotracheal tubes 92 having varyinginside diameters, such as inside diameters from about 3.0 mm, or thesize of a conventional pediatric endotracheal tube 92, to about 9.0 mm,or the size of a convention adult endotracheal tube 92. Alternatively,the endotracheal tube 92 may have an inside diameter smaller than about3.0 mm or larger than about 9.0 mm. Preferably, the ribs 74 will engagethe inside surface of the endotracheal tube 92 in which the rod 72 hasbeen inserted, whether the inside surface has a small inside diameter,such as about 3.0 mm or a larger inside diameter, such as about 9.0 mm.

The proximal end 72 b of the rod 72 includes threads 73 configured forconnecting the rod 72 to a first connecting member 82, shown in FIGS. 8and 8B. The first connecting member 82 includes a base 84 having aplurality of arms 86 extending outward therefrom. The arms 86 includeinwardly extending flanges or locking members 88. A substantiallycylindrical body 90 also extends outwardly from the base 84 between thearms 86. A longitudinally extending threaded channel 95 is formed atleast through the base 84. The first connecting member 82 is configuredto be attached to the threads 73 of the rod 72. This threaded connectionallows the user to adjust the longitudinal position of the firstconnecting member 82 relative to the rod 72, i.e., in the direction ofthe arrow 93 in FIG. 8, by rotating the attachment first connectingmember 82 clockwise or counterclockwise. This threaded connectionfurther allows the user to shorten or lengthen the rod 72 relative tothe length of the tube body 94 of the endotracheal tube 92 that will bemounted on the rod 72. If desired, a portion of the proximal end 72 b ofthe rod 72 that extends outward of the first connecting member 82 may beremoved by the user, such as by cutting. It will be understood that therod 72 may be shortened or lengthened relative to the length of the tubebody 94 by any other means.

Referring to FIG. 8C, a first alternate embodiment of the firstconnecting member is shown at 82′. The first connecting member 82′ issimilar to the first connecting member 82, however, the cylindrical body90 of the first connecting member 82′ includes a portion 90 a extendingoutward of the base 84 for connection to a source of oxygen for example.The portion 90 a may have any desired inside and outside diameter, andmay have any desired length, which may include a length equal to alength of the cylindrical body 90. Alternatively, the portion 90 a mayhave a length shorter or longer than a length of the cylindrical body90. The portion 90 a may be configured for attachment to a source ofoxygen or air, in the same manner that the cylindrical body 98 b of theconventional connector 98 shown in FIG. 9 is configured for attachmentto a source of oxygen or air.

If desired, air flow passageways 91 may be formed through base 84 withinthe portion 90 a, as shown in FIG. 8C. The air flow passageways 91define a flow path for oxygen or air from the source of oxygen or air tothe endotracheal tube 92.

Referring to FIG. 8D, a second alternate embodiment of the firstconnecting member is shown at 182. The first connecting member 182 issimilar to the first connecting member 82, and includes a base 184having a plurality of arms 186 extending outward therefrom. Theillustrated embodiment of the first connecting member 182 includes afirst pair of arms 186 a and a second pair of arms 186 b, only one ofwhich is shown in FIG. 8D, opposite the first pair of arms 186 a. Eachof the arms 186 a and 186 b include inwardly extending locking members188. A substantially cylindrical body 190 also extends outwardly fromthe base 184 between the arms 186 a and 186 b. A longitudinallyextending threaded channel 195 is formed in the base 184. Side walls 192extend outwardly from the base 184 in a direction away from the arms 186a and 186 b at side edges of the base 184. The side walls 192 areextensions of the arms 186 a and 186 b and define opening tabs that,when compressed or urged toward one another, such as by the user, thefirst pair of arms 186 a and the second pair of arms 186 b are urgedaway from each other, thus allowing the user to more easily attach anddetach the flange 98 a of the connector 98 from the first connectingmember 182. If desired, the side walls 192 may be formed on any of theembodiments of the first connecting member, such as the first connectingmembers 82 and 82′.

The guided introducer intubation assembly 38 further includes aconventional endotracheal tube, such as shown at 92 in FIG. 9. Theendotracheal tube 92 is configured for attachment to the rod 72, as bestshown in FIG. 2. The endotracheal tube 92 has a first or distal end 92 aand a second or proximal end 92 b. The endotracheal tube 92 furtherincludes a tube body 94 having balloon cuff 96 at the distal end 92 a,and a conventional connector 98 at the proximal end 92 b thereof. Asdescribed in detail above, the tube body 94 of the endotracheal tube 92may have an inside diameter of from about 3.0 mm to about 9.0 mm.

The connector 98 includes a flange 98 a having a substantiallycylindrical body 98 b extending outwardly from the flange 98 a. The body98 b has a longitudinally extending channel 99 formed therethrough. Anair inflation tube 100 is attached to the balloon cuff 96 and configuredfor attachment to a source of air, such as a syringe.

The connector 98 is configured for attachment to the first connectingmember 82. When attached, the body 98 b is inserted into the body 90 ofthe first connecting member 82 and the flange 98 a is snap fit betweenthe arms 86 and retained between the arms 86 by the locking members 88.The body 98 b of the connector 98 has an outside diameter of about 15mm. Alternatively, the body 98 b may have any other outside diameter. Ifdesired, the conventional connector 98 and the first connecting member82 may be configured such that the body 90 of the first connectingmember 82 is smaller than, and may be inserted into the body 98 b of theconnector 98.

When the guided introducer intubation assembly 38 is assembled, the rod72 is inserted through the channel 99 of the connector 98 and into thetube body 94 of the conventional endotracheal tube 92 until the guidemember portion 78 extends outward of the distal end 92 a of theendotracheal tube 92. When the rod 72 is mounted within the tube body 94of the endotracheal tube 92, the longitudinally extending spaces betweenthe ribs 74 define flow paths for oxygen from a source of oxygen (notshown) to the patient during intubation and before the guided introducerintubation assembly 38 is removed.

Although not illustrated, the rod 72 may be formed as a hollow memberand may also have one or more radially extending holes or perforationsalong its length to facilitate the delivery and flow of oxygen from theproximal end 72 b of the rod 72.

Advantageously, the improved endotracheal tube insertion device 30, andparticularly the shape and tapered leading edge of the ribs 74 (or thealternative ribbed portion of the rod 72 configured as a hollowinflatable member), the smooth, tapered or cone-shaped leading end 72 aof the rod 72. The spherical tip 76, and the guide member portion 78 ofthe improved guided introducer intubation assembly 38 is configured toavoid being caught on laryngeal structures as the guided introducerintubation assembly 38 and the leading edge or distal end 92 a of theendotracheal tube 92 is advanced into the patient's airway, thusfacilitating the delivery of the endotracheal tube 92 between the vocalcords and preventing trauma or injury to the vocal cords and other partsof the airway.

A second embodiment of the intubation assembly rod is shown at 102 inFIG. 10. The rod 102 is similar to the rod 72 and includes the pluralityof longitudinally and radially outwardly extending ribs 104. Theproximal end 102 b of the rod 102 also includes threads 105 configuredfor connecting the rod 102 to the first connecting member 82, describedabove.

The distal end 102 a of the rod 102 is tapered or substantiallycone-shaped and defines a leading end of the rod 102, and includes aguide system configured as a guide sleeve 106 in lieu of the guidemember portion 78 and the spherical tip 76 of the guide rail 75. Theguide sleeve 106 includes a first or distal end 106 a, a second orproximal end 106 b, and has a longitudinally extending substantiallycylindrical channel 106 c formed therethrough. The illustrated guidesleeve 106 is mounted directly to the rod 102 and a bridge, such as thebridges 80 and 112, are not required, but may be provided if desired.

In the illustrated embodiment, the distal and proximal ends 106 a and106 b are tapered. The guide sleeve 106 is configured such that eitherthe optical housing 50 or the flexible member 52, as best shown in FIG.12, may be inserted through the channel 106 c and that the guide sleeve106 can be slidably mounted within the channel member 37.Advantageously, the tapered leading or distal end 106 a of the guidesleeve 106 is also configured for easy and atraumatic advancement intothe patient's airway; i.e., configured to avoid being caught onlaryngeal structures as the guided introducer intubation assembly 38 andthe leading edge or distal end 92 a of the endotracheal tube 92 isadvanced into the patient's airway, thus facilitating the delivery ofthe endotracheal tube 92 between the vocal cords and preventing traumaor injury to the vocal cords and other parts of the airway.

A third embodiment of the intubation assembly rod is shown at 108 inFIG. 12. The distal end 108 a of the rod 108 is tapered or substantiallycone-shaped and defines a leading end of the rod 108. The rod 108includes a guide sleeve 110. The guide sleeve 110 includes a first ordistal end 110 a, a second or proximal end 110 b, and has alongitudinally extending substantially cylindrical channel 110 c formedtherethrough. The guide sleeve 110 is attached to the rod 108 by asubstantially flat bridge 112 that extends between the rod 108 and theguide sleeve 110. The rod 108 is otherwise substantially the same as therod 102. Like the bridge 80, the bridge 112 may be located at anydesired portion of the rod 108. The bridge 112 may have any width andlength, and may be attached to the guide sleeve 110 at any pointproximal to the distal end 110 a of the guide sleeve 110. Further, theguide sleeve 110 may be attached to the rod 108 at any otherlongitudinal location or at any other desired distance from the distalend 108 a of the rod 108. The guide sleeve 110 is configured such thatthe distal end 52 a of the flexible member 52, as shown in FIG. 12, maybe inserted through the channel 110 c. The guide sleeve 110 is furtherconfigured for insertion through the channel 50 c of the optical housing50, the channel 37 c of the channel member 37, and the channel 46 c ofthe channel member 46. Like the bridge 80, the bridge 112 may have anydesired thickness such that the bridge 112 may extend through the slot50 d of the channel 50 c, the slot 37 b of the channel 37 c, and theslot 46 d of the channel 46 c.

FIG. 12A is an end view of the rod 108 and shows a radially inwardlyextending stop member 114 formed at the distal end 110 a of the guidesleeve 110. The stop member 114 may be provided to assist in retainingthe flexible member 52 within the guide sleeve 110 during insertion ofthe endotracheal tube insertion device 30 into the patient's airway.Alternatively, the distal end 110 a of the guide sleeve 110 may includetwo or more of the stop members 114. Although shown formed at the distalend 110 a of the guide sleeve 110, the stop members 114 may be formed atthe proximal end 110 b of the guide sleeve 110, or at any locationbetween the distal and proximal ends 110 a and 110 b. Additionally, thestop members 114 may have any desired shape and size.

Like the guide rail 75 and its component parts, the guide sleeve 110 andthe bridge 112 may be formed from any flexible or semi-flexiblematerial, such as silicon, rubber, wire-reinforced silicon,wire-reinforced rubber, and polymers.

A fourth embodiment of the intubation assembly rod is shown at 116 inFIG. 13. The distal end 116 a of the rod 116 is tapered or substantiallycone-shaped and defines a leading end of the rod 116. The rod 116includes a guide sleeve 118. The guide sleeve 118 includes a first ordistal end 118 a, a second or proximal end 118 b, and has alongitudinally extending substantially cylindrical channel 118 c formedtherethrough. The guide sleeve 118 is attached to the rod 116 by thesubstantially flat bridge 112 that extends between the rod 116 and theguide sleeve 118. The illustrated guide sleeve 118 also includes alongitudinally extending slot 120 formed therethrough. The rod 116 isotherwise substantially the same as the rod 102.

A fifth embodiment of the intubation assembly rod is shown at 122 inFIG. 14. The distal end 122 a of the rod 122 is tapered or substantiallycone-shaped and defines a leading end of the rod 122. The rod 122includes a guide sleeve 124. The guide sleeve 124 is similar to theguide sleeve 118 and includes a first or distal end 124 a, a second orproximal end 124 b, and has a longitudinally extending substantiallycylindrical channel 124 c formed therethrough. The guide sleeve 124 isattached to the rod 122 by the substantially flat bridge 112 thatextends between the rod 122 and the guide sleeve 124. Unlike the guidesleeve 118, the distal end 124 a of the guide sleeve 124 is not tapered.Rather, an end surface of the distal end 124 a is substantiallyperpendicular to an axis A2 of the guide sleeve 124. The rod 122 isotherwise substantially the same as the rod 102.

FIG. 14A is an end view of the rod 122 and shows a first embodiment of astop member 126 formed at the distal end 124 a of the guide sleeve 124.The illustrated stop member 126 includes three radially inwardlyextending legs 128. The stop member 126 may be provided to assist inretaining the flexible member 52 within the guide sleeve 124 duringinsertion of the endotracheal tube insertion device 30 into thepatient's airway. Alternatively, the distal end 124 a of the guidesleeve 124 may include any desired number of the legs 128, such as one,two, or more than three legs 128. Although shown formed at the distalend 124 a of the guide sleeve 124, the stop member 126 may be formed atthe proximal end 124 b of the guide sleeve 124, or at any locationbetween the distal and proximal ends 124 a and 124 b. Additionally, thelegs 128 may have any desired shape and size.

FIG. 14B is an end view of the rod 122 and shows a second embodiment ofthe guide sleeve 124′, wherein the distal end 124′a thereof includesthree of the radially inwardly extending stop members 114. As describedabove, the stop members 114 may be provided to assist in retaining theflexible member 52 within the guide sleeve 124 during insertion of theendotracheal tube insertion device 30 into the patient's airway.Alternatively, the distal end 124′a of the guide sleeve 124′ may includetwo of the stop members 114 or more than three of the stop members 114.Although shown formed at the distal end 124′a of the guide sleeve 124′,the stop members 114 may be formed at the proximal end 124′b of theguide sleeve 124′, or at any location between the distal and proximalends 124′a and 124′b. Additionally, the stop members 114 may have anydesired shape and size. If desired, an outside surface of the distal end52 a of the flexible member 52 may be formed with guide grooves (notshown) corresponding to the stop members 114. The flexible member 52would therefore be slidably movable within the guide sleeve 124′ and thestop members 114 would slidably engage the flexible member 52 within thegrooves.

A sixth embodiment of the intubation assembly rod is shown at 130 inFIG. 15. The distal end 130 a of the rod 130 is tapered or substantiallycone-shaped and defines a leading end of the rod 130. The rod 130includes a guide sleeve 132 having a first or distal end 132 a, a secondor proximal end 132 b, and has a longitudinally extending substantiallycylindrical channel 132 c formed therethrough. The guide sleeve 132 isattached to the rod 130 by the substantially flat bridge 112 thatextends between the rod 130 and the guide sleeve 132. The distal end 132a of the guide sleeve 132 has a frusto-conical shape. The guide sleeve132 is configured to retain a second embodiment of the flexible member,a portion of which is shown at 134. A distal end 134 a of the flexiblemember 134 also has a frusto-conical shape, such that the distal end 134a of the flexible member 134 is retained within the distal end 132 a ofthe guide sleeve 132. Alternatively, the distal end 134 a of theflexible member 134 may be rounded, tapered, or substantiallycone-shaped and defines a leading end of the flexible member 134.Advantageously, the tapered leading or distal end 134 a of the flexiblemember 134 is also configured for easy and atraumatic advancement intothe patient's airway; i.e., configured to avoid being caught onlaryngeal structures like the guided introducer intubation assembly 38shown in FIG. 8, as the leading edge or distal end 92 a of theendotracheal tube 92 is advanced into the patient's airway, thusfacilitating the delivery of the endotracheal tube 92 between the vocalcords and preventing trauma or injury to the vocal cords and other partsof the airway. The rod 130 is otherwise substantially the same as therod 102.

It will be understood that each embodiment of a rod and a guide sleevedescribed herein, including the rod 108 and the guide sleeve 110, therod 116 and the guide sleeve 118, the rod 122 and the guide sleeve 124,and the rod 130 and the guide sleeve 132, may be formed without thesubstantially flat bridge 112. In such embodiments, the sleeves, 110,118, 124, and 132 are mounted directly to the rods 108, 116, 122, and130, respectively. The bridge 112 may have any width and length, and maybe attached to the guide sleeves 110, 118, 124, and 132 at any pointproximal to the distal ends of the guide sleeves 110,118,124, and 132,respectively.

Prior to use, the guided introducer intubation assembly 38 is secured tothe optical assembly 36 by inserting the guide member portion 78 of theguide rail 75 into the intubation assembly guide channel 64 via thefirst portion 64 a until the guide member portion 78 is seated withinthe second portion 64 c of the intubation assembly guide channel 64, thetip 76 is seated within the first portion 64 a of the intubationassembly guide channel 64, and the bridge 80 extends through the secondportion 64 b of the intubation assembly guide channel 64, as shown inFIGS. 2 and 19. The flexible member 52 of the optical assembly 36 may belocked or fixedly positioned relative to the optical housing 50 bymanually moving the mounting post 68 b of the control device 68 into oneof the notches 48.

Alternatively, a mechanical or electro-mechanical movement device (notshown) may be attached to the flexible member 52, between the flexiblemember 52 and the optical housing 50, or between the flexible member 52and any desired portion of the endotracheal tube insertion device 30,and configured to selectively move the flexible member 52 longitudinallywithin the optical housing 50.

Prior to being inserted into the patient's airway, the guided introducerintubation assembly 38 and attached endotracheal tube 92 may bereleasably attached to the endotracheal tube insertion device 30 withinthe attachment member 70, as best shown in FIG. 2.

In use, one operator or user may insert the blade assembly 34, with theattached optical assembly 36 and guided introducer intubation assembly38, into the airway of a patient, until the distal end 35 a of the bladebody 35 is at the epiglottis. The distal end 52 a of the flexible member52 may then be moved outward of a distal end of the channel member 37 togain a view of the vocal cords. The mounting post 68 b of the controldevice 68 is moved out of the notch 48 within which it has beenpositioned, and the distal end 52 a of the flexible member 52 may bemoved outwardly in increments, such as about 0.5 cm increments, up to adistance of about 7 cm. As described above, the distal end 52 a of theflexible member 52 may be moved relative to its axis A1 to gain a betterview of the vocal cords, and may be locked or retained in a positionselected by the user.

The user may then remove the endotracheal tube 92 from within theattachment member 70. Subsequently, the user may slide the guidedintroducer intubation assembly 38 forwardly into the trachea andoutwardly of the guide channel 64 until the tip 76 is about 12 cm belowor beyond the vocal cords, and the balloon cuff 96 is below the vocalcords. The balloon cuff 96 may then be inflated in a conventionalmanner. The blade assembly 34 and the optical assembly 36 may be removedfrom the patient. The guided introducer intubation assembly 38 may thenbe disconnected from the endotracheal tube 92 and also removed from thepatient.

Advantageously, the improved endotracheal tube insertion device 30includes the guided introducer intubation assembly 38, the opticalassembly 36, and the blade assembly 34, that are interconnected andfunction as a single unit during endotracheal tube 92 positioning.

As a further advantage, the improved endotracheal tube insertion device30 is a relatively simple tool that allows a user to gain and maintainfull control of a patient or accident victim's airway without theexperience of one who has performed hundreds or thousands ofendotracheal intubation procedures. Users, such as first responders,without such significant experience may use the improved endotrachealtube insertion device 30 to intubate the airway of a patient with orwithout the assistance of a physician airway specialist who may beviewing remotely, but in real-time, the video of the procedure.

Advantageously, video of the airway may be transmitted via the internetin real time to a specialist anywhere in the world. This allows thespecialist to provide advice and guidance to a less experienced or lessknowledgeable user, whether the user and patient are in a hospital or ata remote accident site.

Although not illustrated, the optical assembly 36 may be formed with alongitudinally extending rail, similar to the guide member portion 78,and the guided introducer intubation assembly 38 may be formed with acorresponding longitudinally extending slot or groove within which therail may be slidably mounted. A stop member, including but not limitedto a retaining ball, such as similar to the spherical tip 76, may beprovided on either a distal or proximal end of the rail or the groove toprevent proximal or rearward movement of the guided introducerintubation assembly 38 along the rail.

A second embodiment of the endotracheal tube insertion device is shownat 230 in FIGS. 16 through 18. In FIG. 16, the endotracheal tubeinsertion device 230 is shown with the guided introducer intubationassembly 38 and the video monitor 40 removed for clarity. Theendotracheal tube insertion device 230 also includes the opticalassembly 36, described above.

Unlike the improved endotracheal tube insertion device 30, the improvedendotracheal tube insertion device 230 does not include the bladeassembly 34. If desired, the endotracheal tube insertion device 230 mayinclude the handle 32. As shown in FIG. 16, the improved endotrachealtube insertion device 230 includes an insertion member configured as asupraglottic member 232 in lieu of the blade 35. The supraglottic member232 includes a first or distal end 232 a, a second or proximal end 232b, has a longitudinally extending passageway 234 formed therethrough,and a longitudinally extending slot 236 formed through a wall thereof.The slot 236 may have any desired length and width. In addition to thegenerally straight shape of the slot 236 shown, the slot 236 may haveany other desired shape, such as a generally serpentine or wavy pattern(not shown) to assist in retaining the guided introducer intubationassembly 38 within the passageway 234.

The slot 236 facilitates removal of the guided introducer intubationassembly 38, as described below. In the illustrated embodiment, thepassageway 234 has a substantially oval cross-sectional shape, as bestshown in FIG. 18, providing space for the illustrated optical assembly36 and the guided introducer intubation assembly 38, not shown in FIGS.16 through 18. In the illustrated embodiment, the optical housing 50 ofthe optical assembly 36 is attached or mounted within the passageway234. It will be understood that the optical housing 50 may be integrallyformed with the supraglottic member 232, or attached by any desiredmeans included with adhesive, by welding, or in a snap-fit arrangementto ensure that the optical housing 50 does not move relative to thesupraglottic member 232 during use.

The guided introducer intubation assembly 38 is described as extendinginto and through the passageway 234 as best shown in FIGS. 17 and 18.Alternatively however, the passageway 234 may be configured large enoughto only allow the optical assembly 36 to fit therein. In such anembodiment, the guided introducer intubation assembly 38 may be attachedto the flexible member 52, but routed outside of the supraglottic member232.

In the illustrated embodiment, and as best shown in FIG. 18, thelongitudinally extending slot 236 is formed at an angle B2 from a planeP1 that vertically bisects the supraglottic member 232 (when viewing thecross-sectional view of the supraglottic member 232 in FIG. 18). In theillustrated embodiment, the angle B2 is within the range of about 30degrees to about 60 degrees from the plane P1. Alternatively, the angleB2 may be any angle from 0 degrees to 360 degrees from the plane P1.

The supraglottic member 232 includes a generally bowl-shapedsupraglottic cuff 237 formed at the distal end 232 a thereof. Thesupraglottic cuff 237 may be conventional in the art and includes a cuffwall 238 and a cuff opening 240 into which the optical assembly 36 andthe guided introducer intubation assembly 38 (not shown in FIGS. 16through 18) extend. The illustrated passageway 234 has a substantiallyoval cross-sectional shape, however the passageway 234 may have anydesired cross-sectional shape, such as substantially circular, andsubstantially rectangular. Additionally, the passageway 234 may have anyother desired diameter or cross-sectional size.

The supraglottic cuff 237 may be a non-inflatable cuff, such as thei-Gel® supraglottic airway manufactured by Intersurgical Ltd. Thenon-inflatable supraglottic cuff 237 may be formed of any gel-like orother substantially soft material designed to provide an anatomical,impression fit over the laryngeal inlet. Preferably, the shape,softness, and contours of the supraglottic cuff 237 accurately mirrorthe perilaryngeal anatomy. Alternatively, the supraglottic cuff 237, orany one or more portions thereof, may be inflatable and thereforeinclude a conventional air inflation tube 242, such as shown in FIG. 18.The air inflation tube 242 may be attached to the supraglottic cuff 237and configured for attachment to a source of air, such as a syringe.Although illustrated in one location, the air inflation tube 242 may beattached to the supraglottic cuff 237 at any desired location. It willbe understood that the supraglottic cuff 237 may have any desired shape,including a shape configured to displace the epiglottis and laryngealstructures to optimize the user's view of the vocal cords.Advantageously, the inflatable supraglottic cuff 237 allows the user tomore easily displace laryngeal structures such as the epiglottis.

In use, the improved endotracheal tube insertion device 230 differs fromthe improved endotracheal tube insertion device 30 in its position inthe larynx for operation. For example, the improved endotracheal tubeinsertion device 230 is designed and configured to be inserted blindlyinto the mouth of a patient and advanced along the hard and soft palatesuntil a distal tip cuff 237 t of the supraglottic cuff 237 is seated inthe hypopharynx with the cuff opening 240 facing the supraglotticstructures. The flexible member 52 may then be advanced within theoptical housing 50, carrying with it the guided introducer intubationassembly 38 in a manner similar to the method described above for use ofthe improved endotracheal tube insertion device 30 having the rigidblade body 35. Once the optical assembly 36 is optimally positioned andlocked facing the vocal cords, the guided introducer intubation assembly38 is advanced forward and off the optical assembly 36, as describedabove, such that the guided introducer intubation assembly 38 ispositioned between the vocal cords and into the trachea.

The endotracheal tube 92 is positioned below the vocal cords and remainsin the trachea. The flexible member 52, optical housing 50, and thesupraglottic member 232 may then be removed together. Advantageously,the slot 236 in the supraglottic member 232 allows the supraglotticmember 232, the flexible member 52, and the optical housing 50 to beremoved from around the endotracheal tube 92, thus allowing theendotracheal tube 92 to remain in a desired position below the vocalcords. Finally, the guided introducer intubation assembly 38 may beremoved from within the endotracheal tube 92.

A third embodiment of the endotracheal tube insertion device is shown at330 in FIGS. 20 and 21. The endotracheal tube insertion device 330 issimilar to the endotracheal tube insertion device 230, includes thevideo monitor 40, and is configured to be used with the endotrachealtube 92 and the flexible member 52.

As shown in FIG. 20, the improved endotracheal tube insertion device 330includes a supraglottic portion 332. The supraglottic portion 332includes a first or distal end 332 a, a second or proximal end 332 b,has a longitudinally extending passageway 334 formed therethrough, and alongitudinally extending slot 336 formed through a wall thereof. Likethe slot 236 described above, the slot 336 may have any desired lengthand width and may have any other desired shape, such as a generallyserpentine or wavy pattern (not shown) to assist in retaining theendotracheal tube 92 within the passageway 334. The passageway 334 mayhave any desired shape, such as a substantially oval cross-sectionalshape or a substantially cylindrical shape. It will be understood thatthe passageway 334 must be large enough to allow the endotracheal tube92 to be inserted therein.

The supraglottic portion 332 includes a generally bowl-shapedsupraglottic cuff 337 formed at the distal end 332 a thereof. Thesupraglottic cuff 337 may be conventional in the art and includes a cuffwall 338 and a cuff opening 340 into which the concentrically arrangedflexible member 52 and endotracheal tube 92 (best shown in FIG. 21)extend. Like the supraglottic cuff 237, the supraglottic portion 332 mayinclude a non-inflatable supraglottic cuff 337, as described above. Thesupraglottic cuff 337, or any one or more portions thereof, may beinflatable, and thus may include the conventional air inflation tube 242as shown in FIG. 18 and described above. The supraglottic cuff 337 mayhave any desired shape, including a shape configured to displace theepiglottis and laryngeal structures to optimize the user's view of thevocal cords. Advantageously, the inflatable supraglottic cuff 337 allowsthe user to more easily displace laryngeal structures such as theepiglottis.

An optical housing portion 350 extends outward of the proximal end 332 bof the supraglottic portion 332. A large opening or sled area 341 isdefined in the optical housing portion 350 adjacent the proximal end 332b of the supraglottic portion 332. The sled area 341 may be any desiredsize sufficient to allow the concentrically arranged flexible member 52and endotracheal tube 92 to be inserted therein. The optical housingportion 350 may be attached to the supraglottic portion 332 by anydesired means, such as with an adhesive, by a threaded connection, or bywelding. Alternatively, the optical housing portion 350 may beintegrally formed with the supraglottic portion 332, as shown in FIG.20.

In the embodiment illustrated in FIG. 20, the flexible member 52 isinserted within the endotracheal tube 92. The endotracheal tube 92 withthe flexible member 52 mounted therein is then inserted through the sledarea 341 and into the passageway 334. The proximal end of the flexiblemember 52 may be secured within the optical housing portion 350 in thesame manner that the flexible member 52 is secured within the secondportion 50 b of the optical housing 50, described above. The proximalend 92 b of the endotracheal tube 92 and the attached connector 98remain within the sled area 341, and may be releasably attached to theoptical housing portion 350 or the flexible member 52.

As described above, the flexible member 52 and the concentricallymounted endotracheal tube 92 extend longitudinally through thepassageway 334 of the supraglottic portion 332. In use, the endotrachealtube insertion device 330 may be inserted into the airway, and theflexible member 52 and the concentrically mounted endotracheal tube 92may then be advanced below the vocal cords. Once the endotracheal tube92 is positioned below the vocal cords, the flexible member 52 and thesupraglottic portion 332 are removed. The flexible member 52 may beremoved from the proximal end 92 b of the endotracheal tube 92. The slot336 in the supraglottic portion 332 allows the supraglottic portion 332to be removed from around the endotracheal tube 92, thus allowing theendotracheal tube 92 to remain in a desired position below the vocalcords.

Referring to FIG. 21, the flexible member 52 and endotracheal tube 92are shown within a portion of the supraglottic portion 332. As shown,the flexible member 52 and endotracheal tube 92 are concentricallyarranged wherein the flexible member 52 is inserted within theendotracheal tube 92, and the endotracheal tube 92 is inserted into thepassageway 334 as described above.

If desired, the distal end 52 a of the flexible member 52 may haveretention features such as ribs 432 having tapered leading edges similarto the ribs 74 on the rod 72, to retain the distal end 92 a of theendotracheal tube 92 about the distal end 52 a of the flexible member 52during insertion into the airway. Alternatively, the distal end 52 a ofthe flexible member 52 may have a frusto-conical shape, as shown in FIG.15, thus also retaining the distal end 92 a of the endotracheal tube 92about the distal end 52 a of the flexible member 52 during insertioninto the airway. Additionally, the distal end 52 a of the flexiblemember 52, in an area generally the same as the area in which thetapered leading edges of the ribs 432 shown in FIG. 21 are formed, maybe configured to include a solid, an expandable, or a hollow inflatableportion, a leading edge of which may be formed with a tapered orsubstantially frusto-conical shaped transition segment where the ribs432 would otherwise begin. Significantly, the ribs 432, particularly theshape and tapered leading edges of the ribs 432, or the alternativedistal end 52 a having the solid, expandable, or inflatable portion andthe corresponding tapered or substantially frusto-conical shapedtransition segment of the flexible member 52 of the improvedendotracheal tube insertion device 330 are configured to prevent theleading edge or distal end 52 a of the flexible member 52 from catchingon laryngeal structures as the flexible member 52 and surroundingendotracheal tube 92 is advanced into the patient's airway, thusfacilitating the delivery of the endotracheal tube 92 between the vocalcords and preventing trauma or injury to the vocal cords and other partsof the airway.

It will be understood that each of the improved endotracheal tubeinsertion devices 30, 230, and 330, illustrated and described herein,may be manufactured in any desired size. For example, the improvedendotracheal tube insertion devices 30, 230, and 330 may be relativelysmall so as to be configured for use with pediatric patients, may berelatively large so as to be configured for use with adult patients.

FIG. 22 is a second embodiment of the flexible member 500. The flexiblemember 500 is similar to the flexible member 52 and is configured as anelongated member having an axis A3. The flexible member 500 includes abody 502 having a substantially cylindrical shape, a first or distal end502 a and a second or proximal end (not shown, but substantially thesame as the proximal end 52 b of the flexible member 52). Like theflexible member 52, the flexible member body 502 may alternatively haveany other desired cross-sectional shape, such as substantially oval,substantially hexagonal, and substantially rectangular. The flexiblemember body 502 includes the video imaging device 60 and the lightsource 62 disposed in first and second longitudinally extendingconduits, described above, and the third longitudinally extendingconduit 58 configured as a suction tube.

The flexible member 500 also includes an intubation assembly rodreceptor 504. The intubation assembly rod receptor 504 is configured asan elongated member having an axis A4, has a substantially cylindricalshape, and includes a first or distal end 504 a. A proximal end 504 b ofthe intubation assembly rod receptor 504 extends radially outwardly andlongitudinally from the body 502 of the flexible member 500 such thatthe axis A4 is parallel to the axis A3 of the flexible member body 502.The intubation assembly rod receptor 504 has a length L2 within therange of about 1 cm to about 5 cm such that the distal end 504 a of theintubation assembly rod receptor 504 is substantially coplanar with thedistal end 502 a of the flexible member body 502.

Alternatively, the intubation assembly rod receptor 504 may have anyother desired cross-sectional shape, such as substantially oval,substantially hexagonal, and substantially rectangular. Further, theintubation assembly rod receptor 504 may have any desired length L2,such as a length from about 0.5 cm to about 10 cm.

FIG. 23 is a third embodiment of the flexible member 510. The flexiblemember 510 includes a body 512 having a substantially cylindrical shape,a first or distal end 512 a, a second or proximal end (not shown, butsubstantially the same as the proximal end 52 b of the flexible member52), and the axis A3. Like the flexible member body 502, the flexiblemember body 512 may alternatively have any other desired cross-sectionalshape, such as substantially oval, substantially hexagonal, andsubstantially rectangular. The flexible member body 512 includes thevideo imaging device 60 and the light source 62 disposed in first andsecond longitudinally extending conduits, described above, and the thirdlongitudinally extending conduit 58 configured as a suction tube.

The flexible member 510 also includes an intubation assembly rodreceptor 514. The intubation assembly rod receptor 514 is configured asan elongated member having the axis A4, has a substantially cylindricalshape, and includes a first or distal end 514 a. A proximal end 514 b ofthe intubation assembly rod receptor 514 has any desired length andextends radially outwardly and longitudinally from the body 512 of theflexible member 510 such that the axis A4 parallel to the axis A3 of theflexible member body 512. The distal end 514 a of the intubationassembly rod receptor 514 extends beyond the distal end 512 a of thebody 512 a distance L3 within the range of about 0.5 cm to about 2.5 cm.Alternatively, the distal end 514 a of the intubation assembly rodreceptor 514 may extend beyond the distal end 512 a of the body 512 anydesired distance L3, such as a distance from about 0.1 cm to about 5 cm.

FIG. 24 is a fourth embodiment of the flexible member 520. The flexiblemember 520 includes a body 522 having a substantially cylindrical shape,a first or distal end 522 a and a second or proximal end (not shown, butsubstantially the same as the proximal end 52 b of the flexible member52), and the axis A3. Like the flexible member body 502, the flexiblemember body 522 may alternatively have any other desired cross-sectionalshape, such as substantially oval, substantially hexagonal, andsubstantially rectangular. The flexible member body 522 includes thevideo imaging device 60 and the light source 62 disposed in first andsecond longitudinally extending conduits, described above, and the thirdlongitudinally extending conduit 58 configured as a suction tube.

The flexible member 520 also includes an intubation assembly rodreceptor 524. The intubation assembly rod receptor 524 is configured asan elongated member having the axis A4, has a substantially cylindricalshape, any desired length, and includes a first or distal end 524 a. Aproximal end 524 b of the intubation assembly rod receptor 524 extendsradially outwardly and longitudinally from the body 522 of the flexiblemember 520 parallel to the axis A3 of the flexible member body 522. Thedistal end 524 a of the intubation assembly rod receptor 524 does notextend all the way to the distal end 522 a of the body 522, but isspaced apart from the distal end 522 a of the body 522 a distance L4within the range of about 0.5 cm to about 2.5 cm. Alternatively, thedistal end 524 a of the intubation assembly rod receptor 524 may bespaced apart from the distal end 522 a of the body 522 any desireddistance L4, such as a distance from about 0.1 cm to about 7 cm.

FIG. 25 is a fifth embodiment of the flexible member 530. The flexiblemember 530 is similar to the flexible member 52 and is configured as anelongated member having the axis A3. The flexible member 530 includes abody 532 having a substantially oval cross-sectional shape, a first ordistal end 532 a and a second or proximal end (not shown, butsubstantially the same as the proximal end 52 b of the flexible member52). Like the flexible member 52, the flexible member body 532 mayalternatively have any other desired cross-sectional shape, such assubstantially hexagonal, substantially rectangular, and substantiallycircular. The flexible member body 532 includes the video imaging device60 and the light source 62 disposed in first and second longitudinallyextending conduits, described above, and the third longitudinallyextending conduit 58 configured as a suction tube.

The flexible member 530 also includes an intubation assembly rodreceptor 534. The intubation assembly rod receptor 534 is configured asan elongated member having the axis A4, has a substantially ovalcross-sectional shape, and includes a first or distal end 534 a. Theintubation assembly rod receptor 534 extends radially outwardly andlongitudinally from the body 532 of the flexible member 500 parallel tothe axis A3 of the flexible member body 532. The intubation assembly rodreceptor 534 is spaced apart from the body 532 by an arcuate slot orgroove 536. The intubation assembly rod receptor 534 may have anydesired length, such as the length L2 (see FIG. 22), and may beconfigured such that the distal end 534 a of the intubation assembly rodreceptor 534 is substantially coplanar with the distal end 532 a of theflexible member body 532. Alternatively, the distal end 534 a may extendbeyond the distal end 532 a of the body 532, such as the length L3 (seeFIG. 23), or may be spaced apart from the distal end 532 a, such as thedistance L4 (see FIG. 24), such that the distal end 534 a of thereceptor 534 does not extend all the way to the distal end 532 a of thebody 532. Additionally, the intubation assembly rod receptor 534 mayhave any other desired cross-sectional shape, such as substantiallyhexagonal and substantially rectangular, and may also be substantiallycylindrical.

FIG. 26 is a sixth embodiment of the flexible member 540. The flexiblemember 540 is similar to the flexible member 52 and is configured as anelongated member having the axis A3. The flexible member 540 includes abody 542 having a substantially cylindrical shape, a first or distal end542 a and a second or proximal end (not shown, but substantially thesame as the proximal end 52 b of the flexible member 52). Like theflexible member body 532, the flexible member body 542 may alternativelyhave any other desired cross-sectional shape, such as substantiallyoval, substantially hexagonal, and substantially rectangular. Theflexible member body 542 includes the video imaging device 60 and thelight source 62 disposed in first and second longitudinally extendingconduits, described above, and the third longitudinally extendingconduit 58 configured as a suction tube.

The flexible member 540 also includes an intubation assembly rodreceptor 544. The intubation assembly rod receptor 544 is configured asan elongated member having an axis A5, and includes a first or distalend 544 a. The intubation assembly rod receptor 544 is formed from thebody 542 and is separated therefrom by an arcuate slot or groove 546.The distal end 544 a of the intubation assembly rod receptor 544 doesnot extend all the way to the distal end 542 a of the body 542, but isspaced apart from the distal end 542 a of the body 542 a distance L5within the range of about 1 cm to about 2.5 cm. Alternatively, thedistal end 544 a of the intubation assembly rod receptor 544 may bespaced apart from the distal end 542 a of the body 542 any desireddistance L5, such as a distance from about 0.5 cm to about 5 cm.

It will be understood that the illustrated intubation assembly rodreceptors, such as the receptors 504, 514, 524, 534, and 544 may beformed at any desired location on the distal ends of the flexiblemembers 500, 510, 520, 530, and 540, and are not limited to thelocations illustrated in the Figures.

It will be also understood that the distal ends 504 a, 514 a, 524 a, 534a, and 544 a of the receptors 504, 514, 524, 534, and 544, respectively,may be formed from, or reinforced with, a substantially rigid material,such as a rigid or semi-rigid polymer, metal, composite, or likematerial, to provide improved rigidity during use.

FIG. 27 is a seventh embodiment of the intubation assembly rod 550 ofthe guided introducer intubation assembly 38. The intubation assemblyrod 550 is similar to the intubation assembly rod 102 shown in FIG. 10,and may include the plurality of longitudinally and radially outwardlyextending ribs 104. Although not shown in FIG. 27, a proximal end of theintubation assembly rod 550 may also include the threads 105 configuredfor connecting the intubation assembly rod 550 to the first connectingmember 82, described above.

It will be understood that each embodiment of the intubation assemblyrod described herein may have features other than the ribs 74 and 104.For example, in lieu of the ribs 74 and 104, the ribbed portion of theintubation assembly rods, including the intubation assembly rod 550 andeach embodiment of the intubation assembly rod described herein, may beconfigured to include a solid, an expandable, or a hollow inflatableportion, a leading edge of which may be formed with a tapered orsubstantially frusto-conical shaped transition segment where the ribs 74or 104 would otherwise begin. This solid, expandable, or inflatableportion of the intubation assembly rod 550 may have, or may be inflatedto have a desired outside diameter corresponding to inside diameter ofan endotracheal tube 92. The ribs 74 and 104, and the structuresproviding an alternative to the ribs 74 and 104, i.e., the solid,expandable, or inflatable portion and the corresponding tapered orsubstantially frusto-conical shaped transition segment, are configuredto avoid being caught on laryngeal structures as the guided introducerintubation assembly 38 and the leading edge or distal end 92 a of theendotracheal tube 92 is advanced into the patient's airway, thusfacilitating the delivery of the endotracheal tube 92 between the vocalcords and preventing trauma or injury to the vocal cords and other partsof the airway.

A distal end 550 a of the rod 550 may be rounded, as illustrated, ortapered, and defines a leading end of the rod 550. The distal end 550 aof the rod 550 may also include a guide system configured as a guidesleeve 552. The guide sleeve 552 includes an open first or distal end552 a, an open second or proximal end 552 b, and has a longitudinallyextending substantially cylindrical channel 552 c formed therethroughand defining an axis A6. The illustrated guide sleeve 552 is configuredsuch that the receptors 504, 514, 524, 534, and 544 may be inserted intothe channel 552 c.

FIG. 28 is an eighth embodiment of the intubation assembly rod 560 ofthe guided introducer intubation assembly 38. The intubation assemblyrod 560 is similar to the intubation assembly rod 550 and may includethe longitudinally and radially outwardly extending ribs 104, describedabove. Although not shown in FIG. 28, the intubation assembly rod 560may also include the threads 105 configured for connecting the rod 560to the first connecting member 82, described above.

A distal end 560 a of the rod 560 may also include a guide systemconfigured as a guide sleeve 562. The guide sleeve 562 includes a closedfirst or distal end 562 a and an open second or proximal end 562 b. Alongitudinally extending substantially cylindrical channel 562 c isformed through the guide sleeve 562 from the closed distal end 562 a tothe open proximal end 562 b, and defining the axis A6. The illustratedguide sleeve 562 is configured such that the receptors 504, 514, 524,534, and 54 may be inserted into the channel 562 c. The distal end 562 aof the guide sleeve 562 may be rounded, as illustrated, or tapered, anddefines a leading end of the rod 560.

FIG. 29 is a ninth embodiment of the intubation assembly rod 570 of theguided introducer intubation assembly 38. The intubation assembly rod570 is similar to the intubation assembly rod 560 and may include thelongitudinally and radially outwardly extending ribs 104, describedabove. Although not shown in FIG. 28, the intubation assembly rod 570may also include the threads 105 configured for connecting theintubation assembly rod 570 to the first connecting member 82, describedabove.

A distal end 570 a of the rod 570 may also include a guide systemcomprising a first guide sleeve 572 and a second guide sleeve 574. Thefirst guide sleeve 572 includes a closed first or distal end 572 a, andan open second or proximal end 572 b formed in the rod 570. Alongitudinally extending substantially cylindrical channel 572 c isformed through the first guide sleeve 572 from the closed distal end 572a to the open proximal end 572 b, and defines the axis A6.

The second guide sleeve 574 is includes an open first or distal end 574a, and an open second or proximal end 574 b. A longitudinally extendingsubstantially cylindrical channel 574 c is formed through the secondguide sleeve 574 from the open distal end 574 a to the open proximal end574 b, and defines an axis A7.

The illustrated first guide sleeve 572 is configured such that thereceptors 504, 514, 524, 534, and 544 may be inserted into the channel572 c. A distal end 572 a of the first guide sleeve 572 may be rounded,as illustrated, or tapered, and defines a leading end of the rod 570.Similarly, the second guide sleeve 574 is configured such that thedistal ends 502 a, 512 a, 522 a, 532 a, and 542 a of the flexible memberbodies 502, 512, 522, 532, and 542, respectively, may be inserted intothe channel 574 c. If desired, the distal end 572 a of the first guidesleeve 572 may be open.

FIG. 30A is a tenth embodiment of the intubation assembly rod 580 of theguided introducer intubation assembly 38. The intubation assembly rod580 is similar to the intubation assembly rod 550, described above, hasa distal end 580 a, and defines an axis A8. The intubation assembly rod580 may include the longitudinally and radially outwardly extending ribs104, described above, and may also include the threads 105 configuredfor connecting the rod 580 to the first connecting member 82. The distalend 580 a of the intubation assembly rod 580 may be rounded, asillustrated, or tapered, and defines a leading end of the intubationassembly rod 580.

The intubation assembly rod 580 may also include a guide systemcomprising a guide sleeve or guide ring 582. The guide ring 582 includesan open first or distal end 582 a and an open second or proximal end 582b. A longitudinally extending substantially cylindrical channel 582 c isformed through the guide ring 582 from the distal end 582 a to theproximal end 582 b thereof and defines the axis A6. If desired, one ormore guide rings 582 may be formed on the intubation assembly rod 580.

The illustrated guide ring 582 is configured such that the receptors504, 514, 524, 534, and 544 may be inserted into the channel 582 c.Alternatively, the guide ring 582 may be configured such that the distalends 502 a, 512 a, 522 a, 532 a, and 542 a of the flexible member bodies502, 512, 522, 532, and 542, respectively, may be inserted into andthrough the channel 582 c.

FIG. 30B is an eleventh embodiment of the intubation assembly rod 580′of the guided introducer intubation assembly 38. The intubation assemblyrod 580′ is similar to the intubation assembly rod 580, described above,has a distal end 580 a′, and defines the axis A8. Like the intubationassembly rod 580, the intubation assembly rod 580′ may include thelongitudinally and radially outwardly extending ribs 104, describedabove, and may also include the threads 105 configured for connectingthe rod 580′ to the first connecting member 82, described above. Thedistal end 580 a′ of the intubation assembly rod 580′ may be rounded, asillustrated, or tapered, and defines a leading end of the intubationassembly rod 580′.

The intubation assembly rod 580′ may also include a guide systemcomprising a guide sleeve or guide ring 582′. The guide ring 582′includes an open first or distal end 582 a′ and an open second orproximal end 582 b′. A longitudinally extending substantiallycylindrical channel 582 c′ is formed through the guide ring 582′ fromthe distal end 582 a′ to the proximal end 582 b′ thereof and defines theaxis A6. If desired, one or more guide rings 582′ may be formed on theintubation assembly rod 580′.

The guide ring 582′ differs from the guide ring 582 in that the distalend 582 a′ of the guide ring 582′, which defines a leading edge duringinsertion of the intubation assembly rod 580′, may be formed at an angle584 relative to the axis A6. In the illustrated embodiment, the angle584 is about 45 degrees. Alternatively, the distal end 582 a′ of theguide ring 582′ may be formed at any desired angle 584 relative to theaxis A6, such as an angle between about 35 degrees and about 65 degrees.Additionally, the proximal end 582 b′ of the guide ring 582′ may beformed at an angle substantially parallel to the distal end 582 a′.Alternatively, the proximal end, as shown by the phantom line 582 b″,may also be formed at an angle 586 relative to the axis A8. For example,the angle 586 may be any desired angle 584 relative to the axis A8, suchas an angle between about 35 degrees and about 65 degrees. It will beunderstood that the proximal ends 582 b′ and 582 b″ define a leadingedge during removal of the intubation assembly rod 580′.

The guide ring 582′ is configured such that the receptors 504, 514, 524,534, and 544 may be inserted into the channel 582 c′. Alternatively, theguide ring 582′ may be configured such that the distal ends 502 a, 512a, 522 a, 532 a, and 542 a of the flexible member bodies 502, 512, 522,532, and 542, respectively, may be inserted into and through the channel582 c′.

Alternatively, the distal ends 550 a, 560 a, 570 a, 580 a, and 580 a′,of the rods 550, 560, 570, 580, and 580′ may be formed as a sphere orball, such as shown at 564 in FIGS. 36 and 37. As shown in FIGS. 36 and37, the intubation assembly rod 560′ is substantially similar to theintubation assembly rod 560, includes the guide sleeve 562′, thelongitudinally extending substantially cylindrical channel 562 c′ formedthrough the guide sleeve 562′ from the closed distal end 562 a′ to theopen proximal end 562 b′. The distal end of the intubation assembly rod560′ is configured as the ball 564.

Alternatively, the distal ends of the embodiments of the intubationassembly rods illustrated and described herein may be curved. Forexample, FIG. 38 shows a twelfth embodiment of the intubation assemblyrod 630 having a curved distal end 630 a. The rod 630 is otherwisesimilar to the intubation assembly rod 72 described above, and mayinclude the plurality of longitudinally and radially outwardly extendingribs 74. A proximal end (not shown) of the intubation assembly rod 630may also include the threads 73 configured for connecting the intubationassembly rod 630 to the first connecting member 82, described above.

As shown in FIG. 38, the distal end 630 a of the intubation assembly rod630 terminates in a spherical shaped tip 634, and defines a leading endof the intubation assembly rod 630. Alternatively, the distal end 630 aof the intubation assembly rod 630 may be rounded or tapered.

Similarly, FIG. 39 shows a thirteenth embodiment of the intubationassembly rod 640 having a curved distal end 640 a. The intubationassembly rod 640 is similar to the rod 560 described above, and mayinclude the plurality of longitudinally and radially outwardly extendingribs 74. A proximal end (not shown) of the intubation assembly rod 630may also include the threads 73 configured for connecting the intubationassembly rod 630 to the first connecting member 82, described above.

The distal end 640 a of the intubation assembly rod 640 may also includea guide system configured as a guide sleeve 642. The guide sleeve 642includes an open first or distal end 642 a, an open second or proximalend 642 b, and has an elongated channel 642 c formed therethrough. Theillustrated guide sleeve 642 is configured such that the receptors 504,514, 524, 534, and 544 may be inserted into the channel 642 c.

FIG. 40 also shows a fourteenth embodiment of the intubation assemblyrod 650 having a curved distal end portion. The intubation assembly rod650 is similar to the intubation assembly rod 640 described above, butincludes a guide sleeve 652 having a closed distal end 652 a. Theintubation assembly rod 650 may include the plurality of longitudinallyand radially outwardly extending ribs 74. A proximal end (not shown) ofthe intubation assembly rod 630 may also include the threads 73configured for connecting the intubation assembly rod 630 to the firstconnecting member 82, described above.

As shown in FIG. 40, a distal end 650 a of the intubation assembly rod650 includes a guide system configured as the guide sleeve 652. Theguide sleeve 652 includes the closed first or distal end 652 a, an opensecond or proximal end 652 b, and has an elongated channel 652 c formedtherethrough. The illustrated guide sleeve 652 is configured such thatthe receptors 504, 514, 524, 534, and 544 may be inserted into thechannel 652 c.

It will be understood that the entire length of any of the embodimentsof the intubation assembly rods illustrated and described herein may becurved. Alternatively, any desired portion of the embodiments of theintubation assembly rods illustrated and described herein may be curved,such as the distal ends thereof, as shown in FIGS. 38 through 40.Advantageously, intubation assembly rods having curved distal endsminimize the possibility of the intubation assembly rod distal end frombeing caught or otherwise hung-up on an anterior wall of the trachea oron other laryngeal structures such as the arytenoids when advancing theintubation assembly, such as the guided introducer intubation assembly38, into the trachea.

As described above, the intubation assembly rods and their componentparts; i.e., the guide systems formed thereon, may be formed from anyflexible or semi-flexible material, such as silicon, rubber,wire-reinforced silicon, wire-reinforced rubber, and polymers.Accordingly, in a free state; i.e., prior to insertion into theendotracheal tube 92, the intubation assembly rods may have a curvedshape. In addition to providing rods with advantageous flexibility wheninserted into a patient's airway, the flexibility of the intubationassembly rods also provides greater control for the user when insertingthe rods into the endotracheal tube 92.

FIGS. 31 and 32 illustrate a second embodiment of the channel member 600configured for attachment to the blade body 35 and further configured toreceive and retain the flexible member 52 of the optical assembly 36, asshown in FIGS. 2 through 4.

As described above and also shown in FIGS. 3 and 4, the blade body 35 issubstantially straight in the longitudinal direction and has an arcuatecross-sectional shape. Alternatively, the blade body 35, and eachembodiment of the blade body described herein, may be formed with thecurved blade body 44, described in detail above and shown in FIG. 11.

The channel member 600 includes a first or distal end 600 a, a second orproximal end (not shown), defines a longitudinally extending channel601, and is attached to the first side 35 c (lower side when viewingFIG. 31) of the blade body 35. The illustrated channel member 600 hassubstantially circular cross-sectional shape. Alternatively, the channelmember 600 may have any desired cross-sectional shape, such assubstantially oval, substantially rectangular, or other geometric shape.

As shown in FIGS. 31 and 32, the channel member 600 is positioned nearthe second edge 35 e 2 of the blade body 35 (the right edge when viewingFIG. 31). Alternatively, the channel member 600 may be positioned nearthe first edge 35 e 1 of the blade body 35 (the left edge when viewingFIG. 31), or at any position intermediate the first edge 35 e 1 and thesecond edge 35 e 2.

The channel member 600 may include one or more endotracheal tuberetention tabs 602 that extend outwardly from the channel member 600.The endotracheal tube retention tab 602 is configured to allow anendotracheal tube, such as the endotracheal tube 92, to be temporarilypositioned and retained thereon or therein.

The retention tab 602 defines a longitudinally extending channel 606,and extends from the second edge 35 e 2 of the blade body 35 (the rightedge when viewing FIG. 31). As also shown in FIG. 31, the retention tab602 has a substantially circular cross-sectional shape and defines anelongated slot 608 that provides access to the channel 606. When viewedin cross-section, the slot 608 may have any desired size, such as about120 degrees of the circumference of the retention tab 602.Alternatively, the slot 608 may be within about 90 degrees to about 180degrees of the circumference of the retention tab 602. The retention tab602 may additionally have any desired cross-sectional shape, such assubstantially oval, substantially rectangular, or other geometric shape.

The retention tabs 602 may have any desired length to help retain,guide, and control the endotracheal tube 92 during its positioning anddelivery into the trachea. Additionally, if more than one retention tab602 is provided, each retention tab 602 may have a different lengthdetermined by its relative position on the channel member 600.

It will be understood that any desired number of endotracheal tuberetention tabs 602 may be provided. Further, the endotracheal tuberetention tabs 602 may be provided at any desired location on thechannel member 600, including at or near the proximal end (not shown inFIGS. 31 and 32) and at or near the distal end 35 a of the blade body35, such as shown in FIG. 32.

The retention tab 602 may be formed from any desired substantially rigidor semi-rigid material, such as PVC, wire-reinforced silicon, andstainless steel. Alternatively, the retention tab 602 may be formed fromany flexible or semi-flexible material, such as silicon, rubber,wire-reinforced silicon, wire-reinforced rubber, and polymers. Inaddition to the flexible or semi-flexible material providing theretention tab 602 with advantageous flexibility when inserted into apatient's airway, this flexibility also provides the retention tab 602,and the slot 608 formed therein, with sufficient flexibility tofacilitate insertion and removal of the endotracheal tube 92 therefrom.

If desired, the blade body 35 may include a camera channel 610 formedalong the first edge 35 e 1 of the blade body 35 (the left edge whenviewing FIG. 31). The camera channel 610 is configured to receive asecond video imaging device 60′, i.e., a video imaging device inaddition to the video imaging device 60 in any of the flexible membersdescribed herein, including the flexible members 52, 500, 510, 520, 530,and 540. The camera channel 610 is further configured to receive asecond light source 62′, i.e., a light source in addition to the lightsource 62 in any one of the flexible members 52, 500, 510, 520, 530, and540.

The second video imaging device 60′ may be the same as the video imagingdevice 60 described above, and may therefore be a CMOS camera, a CCD, afiber optic camera, and any other direct or indirect imaging device.Accordingly, an electrical wire for an imaging device such as the CCDmay extend within the camera channel 610.

The second light source 62′ may be the same as the light source 62described above, and may therefore be an LED lamp or an incandescentbulb mounted at the distal end of the flexible member, such as thedistal end 52 a of the flexible member 52. Alternatively, the secondlight source 62′ may be any other source of light. Additionally, thesecond light source 62′ may be a fiber optic cable connected at itsproximal end to a source of illumination (not shown), such as an LEDlamp, an incandescent bulb, or any other desired light source. The videoimaging devices 60 and 60′ and the light sources 62 and 62′ areoperationally connected to the video monitor 40 and/or the controller 33by one or more flexible electrical and/or optical connectors, shown at66 in FIG. 6. The video monitor 40 may be configured to allow imagesfrom more than one video imaging device 60 and/or 60′ to be viewed onthe same screen, such as in a split screen arrangement. Alternatively,more than one video monitor 40 may be provided to allow images from morethan one video imaging device 60 and/or 60′ to be viewed simultaneously.

FIGS. 33 through 35 illustrate a seventh embodiment of the flexiblemember 620. The flexible member 620 is similar to the flexible member520 shown in FIG. 24. The flexible member 620 includes a body 622 havinga substantially cylindrical shape, a first or distal end 622 a and asecond or proximal end (not shown, but substantially the same as theproximal end 52 b of the flexible member 52), and the axis A3. Like theflexible member body 522, the flexible member body 622 may alternativelyhave any other desired cross-sectional shape, such as substantiallyoval, substantially hexagonal, and substantially rectangular. Theflexible member body 622 includes the video imaging device 60 and thelight source 62 disposed in first and second longitudinally extendingconduits, described above, and the third longitudinally extendingconduit 58 configured as a suction tube.

The flexible member 620 also includes the intubation assembly rodreceptor 624. The intubation assembly rod receptor 624 is configured asan elongated member having the axis A4, has a substantially cylindricalshape, any desired length, and includes a first or distal end 624 a. Aproximal end 624 b of the intubation assembly rod receptor 624 extendsradially outwardly and longitudinally from the body 622 of the flexiblemember 620 parallel to the axis A3 of the flexible member body 622. Thedistal end 624 a of the intubation assembly rod receptor 624 does notextend all the way to the distal end 622 a of the body 622, but isspaced apart from the distal end 622 a of the body 622 the distance L4within the range of about 0.5 cm to about 2.5 cm. Alternatively, thedistal end 624 a of the intubation assembly rod receptor 624 may bespaced apart from the distal end 622 a of the body 622 any desireddistance L4, such as a distance from about 0.1 cm to about 7 cm.

The flexible member body 622 may include one or more endotracheal tuberetention tabs 626 that extend outwardly from the flexible member 620.The endotracheal tube retention tab 626 configured to allow anendotracheal tube, such as the endotracheal tube 92, to be temporarilypositioned and retained thereon or therein. The endotracheal tuberetention tab 626 is substantially the same as the endotracheal tuberetention tab 602, and will not be described in detail further. Theretention tab 626 may have any desired length to help retain, guide, andcontrol the endotracheal tube 92 during its positioning and deliveryinto the trachea. Additionally, if more than one retention tab 626 isprovided, each retention tab 626 may have a different length determinedby its relative position on the flexible member body 622.

The distal end 622 a of the body 622 may include the articulating jointJ, as described above and also illustrated in FIG. 6. In the embodimentof the flexible member 620 illustrated in FIG. 33, the articulatingjoint J is preferably located adjacent the retention tab 626, thusallowing the user to more accurately control the endotracheal tube 92retained on or in the endotracheal tube retention tab 626.

It will be understood that any desired number of endotracheal tuberetention tabs 626 may be provided. Further, the endotracheal tuberetention tabs 626 may be provided at any desired location on theflexible member 620.

In FIG. 33, the endotracheal tube retention tab 626 is shown formed onthe flexible member 620, which is substantially the same as the flexiblemember 520. It will be understood that one or more endotracheal tuberetention tabs 626 may be formed on any of the flexible membersdescribed herein, including the flexible members 52, 500, 510, 520, 530,and 540. It will be further understood that the flexible member 620 maybe formed with one or more endotracheal tube retention tabs 626, butwithout the intubation assembly rod receptor 624.

A portion of a fourth embodiment of the endotracheal tube insertiondevice is shown at 700 in FIG. 41. In FIG. 41, the endotracheal tubeinsertion device 700 is a hybrid of the blade body 35 illustrated inFIGS. 2 through 4 and the endotracheal tube insertion device 230illustrated in FIGS. 16 through 18.

The endotracheal tube insertion device 700 includes a body 702 having ablade body 704 and a generally bowl-shaped supraglottic cuff 706 formedat a distal end 702 a thereof. If desired, the endotracheal tubeinsertion device 700 may include the handle 32, described above.

The blade body 704 is similar to the blade body 35, and includes a firstor distal end 704 a, a second or proximal end (not shown), but which maybe attached to the handle 32 as shown in FIG. 2. Like the blade body 35,the blade body 704 is substantially straight in the longitudinaldirection and has an arcuate cross-sectional shape. As shown in FIG. 41,the blade body 704 may include a third embodiment of the channel member720 configured for attachment to the blade body 704 and furtherconfigured to receive and retain the flexible member 52 and theendotracheal tube 92 therein.

The channel member 720 includes a first or distal end 720 a, a second orproximal end (not shown), defines a longitudinally extending channel722, and is attached to an underside (lower side when viewing FIG. 41)of the blade body 704. The illustrated channel member 720 hassubstantially circular cross-sectional shape, and may include anelongated slot 724 that provides access to the channel 722 andfacilitates removal of the endotracheal tube 92. Alternatively, thechannel member 722 may have any desired cross-sectional shape, such assubstantially oval, substantially rectangular, or other geometric shape.As shown, the flexible member 52 and endotracheal tube 92 areconcentrically arranged wherein the flexible member 52 is insertedwithin the endotracheal tube 92, and the endotracheal tube 92 isinserted into the passageway channel 722.

The channel member 720 may be formed from any desired substantiallyrigid or semi-rigid material, such as PVC, wire-reinforced silicon, andstainless steel. Alternatively, the channel member 720 may be formedfrom any flexible or semi-flexible material, such as silicon, rubber,wire-reinforced silicon, wire-reinforced rubber, and polymers. Inaddition to the flexible or semi-flexible material providing the channelmember 720 with advantageous flexibility when inserted into a patient'sairway, this flexibility also provides the channel member 720, and theslot 724 formed therein, with sufficient flexibility to facilitateinsertion and removal of the endotracheal tube 92 therefrom.

If desired, the distal end 52 a of the flexible member 52 may haveretention and transition features such as the ribs 432 (also shown inFIG. 21) having tapered leading edges similar to the ribs 74 on the rod72, to retain the distal end 92 a of the endotracheal tube 92 about thedistal end 52 a of the flexible member 52 during insertion into theairway. Alternatively, the distal end 52 a of the flexible member 52 mayhave a frusto-conical shape, such as shown in FIG. 15, thus facilitatinginsertion of the flexible member 52 into the airway. Additionally, thedistal end 52 a of the flexible member 52, in an area generally the sameas the area in which the tapered leading edges of the ribs 432 shown inFIG. 41 are formed, may include a solid or an inflatable portion havinga tapered or frusto-conical shaped leading edge.

Significantly, the ribs 432, particularly the shape and tapered leadingedges of the ribs 432, or the alternative distal end 52 a having thesolid or inflatable frusto-conical shaped portion, of the flexiblemember 52 of the improved endotracheal tube insertion device 700 areconfigured to prevent the leading edge or distal end 52 a of theflexible member 52 from catching on laryngeal structures as the flexiblemember 52 and surrounding endotracheal tube 92 is advanced into thepatient's airway, thus facilitating the delivery of the endotrachealtube 92 between the vocal cords and preventing trauma or injury to thevocal cords and other parts of the airway.

If desired, the blade body 704 may include a camera channel 705 formedalong an edge of the blade body 704 (the left edge when viewing FIG.41). The camera channel 705 is configured to receive the second videoimaging device 60′, i.e., a video imaging device in addition to thevideo imaging device 60 in any of the flexible members described herein,including the flexible members 52, 500, 510, 520, 530, and 540. Thecamera channel 705 is further configured to receive the second lightsource 62′, i.e., a light source in addition to the light source 62 inany one of the flexible members 52, 500, 510, 520, 530, and 540.

The supraglottic cuff 706 is similar to the supraglottic cuff 237 of thesupraglottic member 232 described above. The supraglottic cuff 706includes a first or distal end 706 a, a second or proximal end 706 b,has a longitudinally extending passageway 708 formed therethrough, and alongitudinally extending slot 710 formed through a wall thereof. Thepassageway 708 is shown as being much larger than the combined size ofthe blade body 704, the channel member 720, and the camera channel 705positioned therein. However, it will be understood that the supraglotticcuff 706 may be formed with a passageway 708 only large enough toposition the blade body 704, the channel member 720, and the camerachannel 70 therein. The slot 710 may have any desired length and width.In addition to the generally straight shape of the slot 710 shown, theslot 710 may have any other desired shape, such as a generallyserpentine or wavy pattern (not shown) to assist in retaining a guidedintroducer intubation assembly, such as the guided introducer intubationassembly 38 within the passageway 708.

The slot 710 facilitates removal of the guided introducer intubationassembly 38, as described above. In the illustrated embodiment, thepassageway 708 has a substantially oval cross-sectional shape, thusproviding space, such as for the optical assembly 36 and the guidedintroducer intubation assembly 38, not shown in FIG. 41.

The supraglottic cuff 706 may be conventional in the art, is generallybowl-shaped, and includes a cuff wall 712 and a cuff opening 714 intowhich the optical assembly 36 and the guided introducer intubationassembly 38 (not shown in FIG. 41) extend. The illustrated passageway708 has a substantially oval cross-sectional shape, however thepassageway 708 may have any desired cross-sectional shape, such assubstantially circular, and substantially rectangular. Additionally, thepassageway 708 may have any other desired diameter or cross-sectionalsize.

The supraglottic cuff 706 may be formed from any of the gel-like orother substantially soft materials described above and designed toprovide an anatomical, impression fit over the laryngeal inlet.Additionally the portion of the supraglottic cuff 706 in which the slot710 is formed may be formed from any desired substantially rigid orsemi-rigid material, such as PVC, silicon, rubber, wire-reinforcedsilicon, wire-reinforced rubber, and polymers. Providing additionalrigidity to the slot 710 of the supraglottic cuff 706 provides the slot710 sufficient rigidity to maintain its shape and retain theendotracheal tube 92 therein, while also providing sufficientflexibility to facilitate insertion and removal of the endotracheal tube92 from the supraglottic cuff 706.

The supraglottic cuff 706 may be a non-inflatable cuff, such as thei-Gel® supraglottic airway manufactured by Intersurgical Ltd. Thenon-inflatable supraglottic cuff 706 may be formed of any gel-like orother substantially soft material designed to provide an anatomical,impression fit over the laryngeal inlet. Preferably, the shape,softness, and contours of the supraglottic cuff 706 accurately mirrorthe perilaryngeal anatomy. Alternatively, the supraglottic cuff 706, orany one or more portions thereof, may be inflatable and thereforeinclude a conventional air inflation tube, such as the air inflationtube 242 shown in FIG. 18. The air inflation tube 242 may be attached tothe supraglottic cuff 706 and configured for attachment to a source ofair, such as a syringe. It will be understood that the supraglottic cuff706 may have any desired shape, including a shape configured to displacethe epiglottis and laryngeal structures to optimize the user's view ofthe vocal cords. Advantageously, the inflatable supraglottic cuff 706allows the user to more easily displace laryngeal structures such as theepiglottis. The supraglottic cuff 706 may be attached to the blade body704 by any desired method, such as with an adhesive. Alternatively, thesupraglottic cuff 706 may be attached to the blade body 704mechanically, such as with a snap-fit arrangement, or with mechanicalfasteners.

FIGS. 42 through 44 illustrate a fifteenth embodiment of the intubationassembly rod 720 having a curved distal end 720 a. The intubationassembly rod 720 is shown with the flexible member 500 to which theintubation assembly rod 720 may be attached. The flexible member 500includes the body 502 and the intubation assembly rod receptor 504.

The intubation assembly rod 720 is similar to the intubation assemblyrod 650 described above. The intubation assembly rod 720 may include theplurality of longitudinally and radially outwardly extending ribs 74. Aproximal end (not shown) of the intubation assembly rod 720 may alsoinclude the threads 73 configured for connecting the intubation assemblyrod 720 to the first connecting member 82, described above.

As shown in FIGS. 42 through 44, the distal end 720 a of the intubationassembly rod 720 includes a guide system configured as the guide sleeve722. The guide sleeve 722 includes the closed first or distal end 722 a,an open second or proximal end 722 b, and has an elongated channel 722 cformed therethrough. The illustrated guide sleeve 722 is configured suchthat the receptors 504, 514, 524, 534, and 544 may be inserted into thechannel 722 c.

As shown in FIGS. 42 through 44, the distal end 720 a of the intubationassembly rod 720 is bent or curved in two directions. The distal end 720a is curved in the positive x direction (see FIG. 44) toward the body502 of the flexible member 500 (see FIG. 42). The distal end 720 a isalso curved in the negative y direction (see FIG. 44) away from the body502 of the flexible member 500 (to the right when viewing FIG. 43).

Referring now to FIG. 45, an alternate embodiment of an optical assemblyis shown at 36′. The optical assembly 36′ is shown within theendotracheal tube insertion device 230, also shown in FIGS. 16 through18. In the illustrated embodiment, the optical housing 50′ of theoptical assembly 36′ includes a camera channel 51 formed longitudinallyalong an outside surface of the optical housing 50′. The camera channel51 is configured to receive the second video imaging device 60′, i.e., avideo imaging device in addition to the video imaging device 60 in theflexible member 52. The camera channel 51 is further configured toreceive the second light source 62′, i.e., a light source in addition tothe light source 62 in the flexible member 52.

It will be understood that the camera channel 51 may also be provided onany of the embodiments of the optical assemblies described andillustrated herein. Additionally, the camera channel 51 may be formed orotherwise attached to an inside surface of the passageway 234. Thecamera channel 51 may be formed from a substantially rigid material, ormay be formed from the same material as the supraglottic member 232.

The second video imaging device 60′ may be the same as the video imagingdevice 60 described above, and may therefore be a CMOS camera, a CCD, afiber optic camera, and any other direct or indirect imaging device.Accordingly, an electrical wire for an imaging device such as the CCDmay extend within the camera channel 51.

The second light source 62′ may be the same as the light source 62described above, and may therefore be an LED lamp or an incandescentbulb mounted at the distal end of the flexible member, such as thedistal end 52 a of the flexible member 52. Alternatively, the secondlight source 62′ may be any other source of light. Additionally, thesecond light source 62′ may be a fiber optic cable connected at itsproximal end to a source of illumination (not shown), such as an LEDlamp, an incandescent bulb, or any other desired light source. The videoimaging devices 60 and 60′ and the light sources 62 and 62′ areoperationally connected to the video monitor 40 and/or the controller 33by one or more flexible electrical and/or optical connectors, shown at66 in FIG. 6. The video monitor 40 may be configured to allow imagesfrom more than one video imaging device 60 and/or 60′ to be viewed onthe same screen, such as in a split screen arrangement. Alternatively,more than one video monitor 40 may be provided to allow images from morethan one video imaging device 60 and/or 60′ to be viewed simultaneously.

Referring now to FIG. 46, an end view of a third embodiment of the bladeassembly is shown at 800. The blade assembly 800 includes the blade body35 and a channel member 801 configured to receive and retain theflexible member 52 of the optical assembly 36 and the endotracheal tube92. As shown, the flexible member 52 and endotracheal tube 92 areconcentrically arranged wherein the flexible member 52 is insertedwithin the endotracheal tube 92, and the endotracheal tube 92 isinserted into a channel 802 of the channel member 801.

As described above and also shown in FIGS. 3 and 4, the blade body 35 issubstantially straight in the longitudinal direction and has an arcuatecross-sectional shape. Alternatively, the blade body 35, and eachembodiment of the blade body described herein, may be formed with thecurved blade body 44, described in detail above and shown in FIG. 11.

The channel member 801 is attached to the first side 35 c (lower sidewhen viewing FIG. 46) of the blade body 35. The illustrated channelmember 801 has substantially circular cross-sectional shape.Alternatively, the channel member 801 may have any desiredcross-sectional shape, such as substantially oval, substantiallyrectangular, or other geometric shape.

As shown in FIG. 46, the channel member 801 is positioned near thesecond edge 35 e 2 of the blade body 35 (the right edge when viewingFIG. 46). Alternatively, the channel member 801 may be positioned nearthe first edge 35 e 1 of the blade body 35 (the left edge when viewingFIG. 46), or at any position intermediate the first edge 35 e 1 and thesecond edge 35 e 2.

The channel member 801 has an elongated and longitudinally extendingslot 804 formed therein that provides access to the channel 802.

As shown in FIG. 46, the slot 804 of the channel member 801 opens towardthe second edge 35 e 2 of the blade body 35 (the right edge when viewingFIG. 46). Alternatively, the slot 804 of the channel member 801 may openin any desired direction, such as toward the first edge 35 e 1 of theblade body 35 (the left edge when viewing FIG. 31). As also shown inFIG. 46, the channel member 801 is positioned near the second edge 35 e2 of the blade body 35 (the right edge when viewing FIG. 46).Alternatively, the channel member 801 may be positioned near the firstedge 35 e 1 of the blade body 35 (the left edge when viewing FIG. 46),or at any position intermediate the first edge 35 e 1 and the secondedge 35 e 2.

Although not shown in FIG. 46, the distal end 52 a of the flexiblemember 52 may have retention features such as the ribs 432 (also shownin FIGS. 21 and 41) having tapered leading edges similar to the ribs 74on the rod 72, to retain the distal end (not shown in FIG. 46) of theendotracheal tube 92 about the distal end (not shown in FIG. 46) of theflexible member 52 during insertion into the airway. Alternatively, thedistal end (not shown in FIG. 46) of the flexible member 52 may have afrusto-conical shape, such as shown in FIG. 15, thus facilitatinginsertion of the flexible member 52 into the airway. Additionally, thedistal end (not shown in FIG. 46) of the flexible member 52, in an areagenerally the same as the area in which the tapered leading edges of theribs 432, such as shown in FIG. 41, are formed, may include a solid oran inflatable portion having a tapered or frusto-conical shaped leadingedge.

Significantly, the ribs 432, particularly the shape and tapered leadingedges of the ribs 432, or the alternative distal end (not shown in FIG.46) having the solid or inflatable frusto-conical shaped portion, of theflexible member 52 of the improved blade assembly 800 are configured toprevent the leading edge or distal end (not shown in FIG. 46) of theflexible member 52 from catching on laryngeal structures as the flexiblemember 52 and surrounding endotracheal tube 92 are advanced into thepatient's airway, thus facilitating the delivery of the endotrachealtube 92 between the vocal cords and preventing trauma or injury to thevocal cords and other parts of the airway.

Referring now to FIG. 47, a portion of an endotracheal tube insertiondevice is shown at 810 and includes a handle 812 and an alternativeembodiment of a blade body 814. The handle may be substantially the sameas the handle 32. The blade body 814 includes a first blade portion 816and a second blade portion 818 pivotally connected together by pivotmechanism 820 about a pivot axis 820 a. The pivot mechanism 820 isconfigured to allow the second blade portion 818 to be pivotally movedrelative to the first blade portion 816 about the pivot axis 820 a inthe direction of the arrows 821 a and 821 b.

The blade body 814 is elongated and upwardly curved, and thus has ashape similar to the blade body 44. If desired, the second blade portion818 may be bent inwardly, (toward the handle 812 when viewing FIG. 47)at a point intermediate a distal end 818 a of the second blade portion818 and the pivot axis 820 a. The second blade portion 818 may beinwardly bent any desired angle AA, such as within the range of about115 degrees to about 175 degrees. This increased bend angle at thesecond blade portion 818; i.e., the distal end of the blade body 14,advantageously allows the user, such as a physician to achieve a morepronounced tissue retraction and anterior camera angulation.Alternatively, the blade body 814 may also be straight, such as theblade body 35, and include the pivot mechanism 820 and/or have a distalend portion inwardly bent at the angle AA.

The blade body 814 may be used in lieu of the blades illustrated in anyembodiments of the endotracheal tube insertion device described herein.Additionally, the blade body 814 may be used in lieu of the blade body704 of the endotracheal tube insertion device 700 shown in FIG. 41.

Referring now to FIG. 48, an alternate embodiment of a flexible memberis shown at 822. Like the embodiments the flexible member describedherein above, the flexible member 822 is an elongated member having anaxis A9. The flexible member 822 further includes a body 824 having asubstantially cylindrical shape. A first or distal end 826 of theflexible member 822 is enlarged. In the illustrated embodiment, thedistal end 826 has a substantially barrel shape. A positioning plug 828extends radially outward of the flexible member 822 intermediate thebody 824 and the distal end 826. Alternatively, the distal end 826 mayhave other desired shapes, such as football shaped, or spherical. Ifdesired, the barrel shape, football shape, spherical, or other shapestructure of the distal end 826 may be configured to be inflatable orcompressible.

As also described above, a plurality of longitudinally extendingconduits is formed within the flexible member 822. As shown in FIG. 48,the flexible member 822 includes the first longitudinally extendingconduit 54, the second longitudinally extending conduit 56, and thethird longitudinally extending conduit 58. The video imaging device 60is disposed in the first longitudinally extending conduit 54. A lightsource 62 is disposed in the second longitudinally extending conduit 56.The third longitudinally extending conduit 58 is configured as a suctiontube and is connected to a vacuum port, such as the vacuum port 59extending outward of the knob 68 a shown in FIG. 5.

In FIG. 48, a conventional endotracheal tube 830 is shown concentricallymounted on the flexible member 822. The endotracheal tube 830 has afirst or distal end 830 a and a second or proximal end (not shown). Theendotracheal tube 830 further includes a tube body 832 having ballooncuff 834 near the distal end 830 a. A conventional Murphy eye 836 isformed between the cuff 834 and the distal end 830 a. As shown, thepositioning plug 828 is configured to extend through the Murphy eye 836to hold the endotracheal tube 830 in place relative to the flexiblemember 822 during insertion into the airway. It will be understood thatall embodiments of the intubation assembly rods disclosed herein may beformed having the positioning plug 828.

Preferably, the widest outside diameter 826 od of the barrel shapeddistal end 826 of the flexible member 822 is equal to or slightly largerthan an outside diameter of the endotracheal tube 830. If the materialforming the distal end 826 of the flexible member 822 is notcompressible, only a portion of its outside diameter may be equal to orslightly larger than the outside diameter of the endotracheal tube 830so the flexible member 822 may fit through and be removed from theinside of the endotracheal tube 830.

Referring now to FIG. 49, a portion of an endotracheal tube insertiondevice is shown at 837. The endotracheal tube insertion device 837 issimilar to the endotracheal tube insertion device 330 in FIG. 21 and theendotracheal tube insertion device 700 in FIG. 41, and includes theendotracheal tube 92 attached to the connector 98, both described indetail above and concentrically mounted on a flexible member, such asthe flexible member 822. A video monitor, schematically illustrated at40 is attached to a proximal end of an optical assembly of which theflexible member 822 is a component and, as described above, isoperationally connected to a video imaging device (not shown), such asthe video imaging device 60 shown in FIG. 7.

A first embodiment of an oxygen source cap 838 is mounted concentricallyabout the flexible member 822 between a proximal end 827 thereof and theendotracheal tube connector 98. The oxygen source cap 838 has a body 839having a circumferentially extending wall 840 defining a generallycylindrical outside surface, a first end 842 (the upper end when viewingFIG. 49), and a second end 844 (the lower end when viewing FIG. 49). Alongitudinally extending slit 846 is formed through the wall 840 anddefines a closure member. The slit 846 may be opened to allow the oxygensource cap 838 to be mounted on the flexible member 822 and closed toallow the oxygen source cap 838 to be attached to the flexible member822.

An end wall 848 is formed at the first end 842 and has an aperture 850formed centrally therethrough. When the oxygen source cap 838 is mountedon the flexible member 822, the end wall 848 provides a fluid-tight sealabout the flexible member 822. The second end 844 of the oxygen sourcecap 838 is open. A generally cylindrical fluid inlet 852 extendsradially outward of the wall 840 and is in fluid communication with theopen second end 844 of the oxygen source cap 838. The fluid inlet 852may be connected to source of oxygen, schematically illustrated at 854.

In operation, the oxygen source cap 838 may be urged into contact withthe connector 98 such that a proximal end 98 c of the connector 98 isinserted into the open second end 844 of the oxygen source cap 838.Oxygen from the source of oxygen 854 may then flow through the oxygensource cap 838 into the endotracheal tube 92 via the longitudinallyextending channel 99 of the connector 98; i.e., in the direction of thearrow 856.

Referring now to FIG. 50, a first embodiment of a handle and bladeassembly is shown at 860. The handle and blade assembly 860 isconfigured for use with an endotracheal tube insertion device, such asthe endotracheal tube insertion device 30 in FIG. 2, and includes ahandle 862 and a blade 864. The blade 864 is similar to the blade body34, but includes a longitudinally extending notch 866 at distal endthereof.

The blade 864 is elongated and extends in a first direction. The handle862 is arcuate and extends rearwardly from the blade 864. Alternatively,the handle 862 may have any other desired shape.

If desired, the blade 864 may be pivotally attached to the handle 862about a pivot axis 868 such that the blade 864 may be pivoted relativeto the handle 862 clockwise or counterclockwise (see the arrow 869). Thehandle and blade assembly 860 may also be provided with a mechanism (notshown) to lock or prevent the blade 864 from pivoting relative to thehandle 862, or to otherwise control the pivoting movement of the blade864 relative to the handle 862.

Referring now to FIG. 51, a second embodiment of a handle and bladeassembly is shown at 870. The handle and blade assembly 870 isconfigured for use with an endotracheal tube insertion device, such asthe endotracheal tube insertion device 30 in FIG. 2, and includes ahandle 872 and the blade 864 having the notch 866.

The blade 864 is elongated and extends in a first direction. The handle872 is arcuate, extends forwardly toward a distal end of the blade 864.Alternatively, the handle 872 may have any other desired shape.

If desired, the blade 864 may be pivotally attached to the handle 872about a pivot axis 874 such that the blade 864 may be pivoted relativeto the handle 872 clockwise or counterclockwise (see the arrow 876). Thehandle and blade assembly 870 may also be provided with the mechanism(not shown) to lock or prevent the blade 864 from pivoting relative tothe handle 872, or to otherwise control the pivoting movement of theblade 864 relative to the handle 872.

FIG. 52 is an enlarged top plan view of an alternative embodiment of ablade assembly 880. The blade assembly 880 includes the blade 864 havingthe notch 866. A channel member 882 is attached to an underside of theblade 864 at the notch 866. The channel member 882 may be any of thechannel members described and illustrated herein above, including butnot limited to the retention tabs 39 a, 39 b, 49 a, 49 b, 602, and 626,or any of the optical assembly channel members described and illustratedherein.

FIG. 53 illustrates a sixteenth embodiment of the intubation assemblyrod 900 shown inserted through the longitudinally extending channel 99of the conventional endotracheal tube connector 98 and into theconventional endotracheal tube 92. The intubation assembly rod 900 hasan elongated body 901 having a proximal end 902 (the upper end whenviewing FIG. 53) and a distal end (not shown) opposite the proximal end902. The proximal end 902 further has a radially extending flangedefining a stop 904 extending therefrom.

One or more longitudinally extending conduits may be formed within theintubation assembly rod 900. As shown in FIG. 53, the intubationassembly rod 900 includes two such conduits: a first longitudinallyextending conduit 906, and a second longitudinally extending conduit908. A guidewire 910 is disposed in the first longitudinally extendingconduit 906. The second longitudinally extending conduit 908 isconfigured as a suction tube and thus may be connected to a vacuum port(not shown in FIG. 53), such as the vacuum port 59 extending outward ofthe knob 68 a, shown in FIG. 5. Although described as a suction tube,the second longitudinally extending conduit 908 may also be used toprovide oxygen to a patient. Alternatively, each of the firstlongitudinally extending conduit 906 and the second longitudinallyextending conduit 908 may be used for any other desired purpose.

The stop 904 is configured to help retain the intubation assembly rod900 in a desired position within the endotracheal tube 92. The stop 904may be attached to the proximal end 902 of the intubation assembly rod900. Alternatively, the stop 904 may be movably mounted to the proximalend 902 of the intubation assembly rod 900 and thus configured to slidealong the length of the intubation assembly rod 900. In lieu of the stop904 being configured as a flange, the proximal end 902 of the intubationassembly rod 900 may include other structures, such as a threadedretainer, a snap close mechanism, a snap sideways mechanism, a resilientstopper, and other similar structures configured to retain theintubation assembly rod 900 in a desired position within theendotracheal tube 92 and to prevent accidental migration into thetrachea. It will be understood that the stop 904 and the alternativestructures described herein above, may be used with any of theembodiments of the intubation assembly rods described herein and withany of the embodiments of the flexible members describe herein.

The proximal end 902 of the intubation assembly rod 900 may also beconfigured to be adjustable in length so as to accommodate endotrachealtubes 92 having a plurality of lengths. In an embodiment wherein thestop 904 is movably mounted to the proximal end 902 of the intubationassembly rod 900, the stop may be positioned to allow for endotrachealtubes 92 having a plurality of different lengths.

FIG. 54 illustrates a seventeenth embodiment of the intubation assemblyrod 920 shown inserted through the longitudinally extending channel 99of the conventional endotracheal tube connector 98 and into theconventional endotracheal tube 92 (not shown in FIG. 54). The intubationassembly rod 920 has an elongated body 921 having a proximal end 922(the upper end when viewing FIG. 54) and a distal end (not shown)opposite the proximal end 922. If desired, the proximal end 922 mayinclude an end portion 924 that extends at about a 90 degree angletherefrom. Alternatively, the end portion 924 may extend at any otherdesired angle relative to an axis of the intubation assembly rod 920,such as within the range of about 0 degrees to about 180 degrees.

A longitudinally extending conduit 926 may be formed within theintubation assembly rod 920. In FIG. 54, the longitudinally extendingconduit 926 is configured as a suction tube and thus may be connected toa vacuum port, shown schematically at 927 in FIG. 54, and similar to thevacuum port 59 extending outward of the knob 68 a, shown in FIG. 5.Although described as a suction tube, the longitudinally extendingconduit 926 may also be used to provide oxygen to a patient.Alternatively, the longitudinally extending conduit 926 may be used forany other desired purpose.

A second embodiment of an oxygen source cap 930 is mountedconcentrically about the intubation assembly rod 920 between theproximal end 922 thereof and the endotracheal tube connector 98. Theoxygen source cap 930 has a body 932 having a circumferentiallyextending wall 934 defining a generally cylindrical outside surface, afirst end 936 (the upper end when viewing FIG. 54), and a second end(the lower end when viewing FIG. 54) that defines an annular collar 938.A portion of the body 932 adjacent the collar 938 is configured as abellows 940. Alternatively, the portion of the body 932 adjacent thecollar 938 may have any structure configured to allow the body 932 toexpand and contract longitudinally. Preferably, the bellows 940 willallow the oxygen source cap 930 to expand up to about 6 cm.Alternatively, the bellows 940 will allow the oxygen source cap 930 toexpand within the range of up to about 10 cm from its fixed orunexpanded condition.

An end wall 942 is formed at the first end 936 of the oxygen source cap930 and has an aperture 944 formed centrally therethrough. When theoxygen source cap 930 is mounted on the intubation assembly rod 920, theend wall 942 provides a fluid-tight seal about the intubation assemblyrod 920. The end wall 942 may be attached to the proximal end 922 of theintubation assembly rod 920. Alternatively, the end wall 942 may bemovably mounted to the proximal end 922 of the intubation assembly rod920 and thus configured to slide along the length of the intubationassembly rod 920.

The elongated body 921 may have a proximal end 922 that is closed andmounted flush with the end wall 942. In such an embodiment, the end wall942 may be formed without the aperture 944, and the intubation assemblyrod 920 may be attached thereto. If desired, the intubation assembly rod920 may be formed without the conduit 926 or may be formed with aplurality of conduits, such as the conduits 906 and 908 described above.

The collar 938 at the second end of the oxygen source cap 930 is open. Agenerally cylindrical fluid inlet 946 extends radially outward of thewall 934 and is in fluid communication with the open collar 938 of theoxygen source cap 930. An axis of the fluid inlet 946 may be oriented inany desired direction relative to an axis of the oxygen source cap 930.Additionally, the fluid inlet 946 may be formed on the end wall 942 ifdesired. The fluid inlet 946 may be connected to source of oxygen,schematically illustrated at 854.

An annular stop 948 includes a centrally formed aperture 950 throughwhich the intubation assembly rod 920 may extend, and a plurality of airflow holes 952 formed therethrough. The stop 948 may be fixedly attachedto the intubation assembly rod 920 and may be attached within the collar938. Alternatively, the stop 948 may be movably mounted to theintubation assembly rod 920 and thus configured to slide along a portionof the of the intubation assembly rod 920. In the illustratedembodiment, four air flow holes 952 are shown. Alternatively, anydesired number of air flow holes 952 may be formed in the annular stop948.

If desired, the intubation assembly rod 920 may terminate at a firstside of the stop 948 (the upwardly facing side when viewing FIG. 54).

In operation, the oxygen source cap 930 may be urged into contact withthe connector 98 such that a proximal end 98 c of the connector 98engages the stop 948 of the oxygen source cap 930. Oxygen from thesource of oxygen 854 may then flow through the oxygen source cap 930into the endotracheal tube 92 via the longitudinally extending channel99 of the connector 98; i.e., in the direction of the arrow 954.

Additionally, the bellows 940 of the oxygen source cap 930 allows theoxygen source cap 930 to be selectively extended a distance, such as upto about 6 cm to facilitate a secure connection between the oxygensource cap 930 and the proximal end 98 c of the connector 98particularly when the endotracheal tubes 92 are of different lengths.

An alternate embodiment of a stop 996 is shown in FIG. 59 mounted aboutan intubation assembly rod 998. The stop 996 has a disk-shaped body 1000and has an aperture 1004 formed therethrough. In FIG. 59, the aperture1004 is configured as a plurality of connected apertures. The aperture1004 includes a first aperture portion 1006 and a second apertureportion 1008. Both aperture portions 1006 and 1008 are substantiallycircular. The diameter of the second aperture portion 1008 is aboutequal to a diameter of the intubation assembly rod 998, such that wheninserted therein, the intubation assembly rod 998 is held within thesecond aperture portion 1008, such as in a snap-fit arrangement. Adiameter of the first aperture portion 1006 is slightly larger than thediameter of the second aperture portion 1008.

The first aperture portion 1006 and the second aperture portion 1008 ofthe aperture 1004 facilitate the movement of the stop 996 along theintubation assembly rod 998. For example, to move the stop 996longitudinally along the rod 998, the rod 998 may be positioned in thefirst aperture portion 1006 and the stop 996 may then be movedlongitudinally to a desired position. When the stop 996 is positionedlongitudinally in the desired position, the stop 996 may be attached tothe rod 998 by moving the stop 996 laterally such that the rod 998 movesfrom the first aperture portion 1006 to the second aperture portion 1008and is attached therein, such as in a snap-fit arrangement.

Referring now to FIG. 55, a third embodiment of a handle and bladeassembly is shown at 960. The handle and blade assembly 960 isconfigured for use with an endotracheal tube insertion device, such asthe endotracheal tube insertion device 30 in FIG. 2, and includes ahandle 962 and a blade 964. The handle 962 has a first end 962 a and asecond end 962 b. It will be understood that the handle 962 may be usedwith any of the embodiments of the insertion members described herein.If desired, the blade 964 may be pivotally attached to the handle 962,as shown in FIGS. 50 and 51.

A video monitor 40 is attached to the first end 962 a of the handle 962and is operationally connected to a video imaging device, such as thevideo imaging device 60, shown in FIG. 7. A channel member 966 and/or anoptical housing 968 may be attached to the blade 964.

As shown in FIGS. 55 and 56, the first end 962 a of the handle 962,i.e., the end to which the video monitor 40 is attached, is bent orcurved in two directions, wherein each of the two directions define axesdifferent from an axis of the second end 962 b of the handle 962. Thefirst end 962 a is curved in the negative x direction (see FIG. 55) andis also curved in the negative y direction (see FIG. 56) away from theblade 964.

It will be understood that all embodiments of the portions of theendotracheal tube insertion devices disclosed herein, including allembodiments of insertion members, optical assemblies, optical housings,flexible members, channel members, and intubation assembly rods, thatmay be inserted into an airway may be shrouded, such as with a shroudformed from nylon, polyurethane, polyester, or silicone, may be encasedin a disposable sheath, or may be formed as a one-time use disposableitem.

It will be further understood that all embodiments of the intubationassembly rods disclosed herein may be formed curved, i.e., having aslightly arcuate shape that corresponds to the natural curvature of aconventional endotracheal tube. This arcuate shape allows for moreintuitive placement into the endotracheal tube and facilitates easierpassage in and out of the endotracheal tube.

Referring now to FIG. 57, a portion of an eighteenth embodiment of anintubation assembly rod is shown at 970. In FIG. 57, the conventionalendotracheal tube 830 is shown concentrically mounted on the intubationassembly rod 970. The endotracheal tube 830 has the first or distal end830 a and the second or proximal end (not shown). The endotracheal tube830 further includes the tube body 832 having the balloon cuff 834 nearthe distal end 830 a. A conventional Murphy eye 836 is formed betweenthe cuff 834 and the distal end 830 a.

Like the embodiments the intubation assembly rods described hereinabove, the intubation assembly rod 970 has an elongated substantiallycylindrical body 972 having a distal end 974 (the upper end when viewingFIG. 57) and a proximal end (not shown) opposite the distal end 974. Thedistal end 974 of the intubation assembly rod 970 is enlarged such thatthe widest outside diameter 974 od of the enlarged distal end 974 isequal to or slightly larger than an outside diameter of the endotrachealtube 830. If the material forming the distal end 974 of the intubationassembly rod 970 is not compressible, only a portion of its outsidediameter may be equal to or slightly larger than the outside diameter ofthe endotracheal tube 830 so the intubation assembly rod 970 may fitthrough and be removed from the inside of the endotracheal tube 830.

In the embodiment illustrated in FIG. 57, the distal end 974 has a firstportion 976 having a substantially barrel shape and a second portion 978having a substantially semi-spherical shape. A positioning plug 980extends radially outward of the intubation assembly rod 970 intermediatethe body 972 and the distal end 974. As shown, the positioning plug 980is configured to extend through the Murphy eye 836 to hold theendotracheal tube 830 in place relative to the intubation assembly rod970 during insertion into the airway. It will be understood that allembodiments of the intubation assembly rods disclosed herein may beformed having the positioning plug 980.

Alternatively, the distal end 974 may have other desired shapes orcombinations of shapes, such as football shaped, spherical,semi-spherical, or other rounded shapes. If desired, the barrel shape,football shape, spherical, semi-spherical, or other rounded shapedstructure of the distal end 826 may be configured to be inflatable orcompressible. Additionally, the distal end 974 of the intubationassembly rod 970 may have only one such enlarged shape.

Advantageously, the barrel shaped first portion 976, such as illustratedin FIG. 57, when formed on the intubation assembly rod 970 (or on any ofthe intubation assembly rods or flexible members described herein),blocks, deflects, and prevents the leading or distal end 974 of theintubation assembly rod 970 and the leading or distal end 830 a of theendotracheal tube 830 from colliding into laryngeal structures such asthe right arytenoid as the endotracheal tube 830 is passed forwardtoward the vocal cords and trachea.

If desired, the intubation assembly rod 970 may also include one or morelongitudinally extending conduits, such as the conduits 906 (not shownin FIG. 57) and 908, formed therethrough for any of the purposesdescribed above, including but not limited to one or more conduits forthe video imaging device 60, the light source 62, a suction tube, or anoxygen supply tube.

It will be understood that the distal end 826 of the flexible member 822shown in FIG. 48, may also have the shape of the distal end 974 shown inFIG. 57. Similarly, the distal end 974 of the intubation assembly rod970 may have the shape of the distal end 826 shown in FIG. 48.

Referring now to FIG. 58, a portion of a nineteenth embodiment of anintubation assembly rod is shown at 982. In FIG. 58, the conventionalendotracheal tube 830 is shown concentrically mounted on the intubationassembly rod 970.

Like the embodiments of the intubation assembly rods described hereinabove, the intubation assembly rod 982 has an elongated substantiallycylindrical body 984 having a distal end 986 (the upper end when viewingFIG. 58) and a proximal end (not shown) opposite the distal end 986. Thedistal end 986 of the intubation assembly rod 982 is also enlarged andhas a first portion 988 and a second portion 990. As shown, the firstportion 988 is configured as a rounded protruding portion, the widestpoint of which, i.e., the portion that extends the greatest distancetransversely from an axis of the intubation assembly rod 982, extendstransversely outward of or overhangs, an outside surface 992 of theendotracheal tube 830 (the right half of the distal end 986 when viewingFIG. 58).

The second portion 990 is also rounded and has a substantiallysemi-spherical shape. Advantageously, the rounded protruding firstportion 988, such as illustrated in FIG. 58, when formed on theintubation assembly rod 982 (or on any of the intubation assembly rodsor flexible members described herein), blocks, deflects, and preventsthe leading or distal end 986 of the intubation assembly rod 982 and theleading or distal end 830 a of the endotracheal tube 830 from collidinginto laryngeal structures such as the right arytenoid as theendotracheal tube 830 is passed forward toward the vocal cords andtrachea.

A positioning plug 994 extends radially outward of the intubationassembly rod 982 intermediate the body 984 and the distal end 986. Asshown, the positioning plug 994 is configured to extend through theMurphy eye 836 to hold the endotracheal tube 830 in place relative tothe intubation assembly rod 982 during insertion into the airway.

It will be understood that the distal end 826 of the flexible member 822shown in FIG. 48, may also have a shape similar to the distal end 986 ofthe intubation assembly rod 982 shown in FIG. 58 and thus may includethe first portion 988 and the second portion 990 having the shapes shownat 986 in FIG. 58.

If desired, the intubation assembly rod 982 may also include one or morelongitudinally extending conduits, such as the conduits 906 (not shownin FIG. 58), 907, and 908, formed therethrough for any of the purposesdescribed above, including but not limited to one or more conduits forthe video imaging device 60, the light source 62, a suction tube, or anoxygen supply tube.

The principle and mode of operation of this invention have beenexplained and illustrated in its preferred embodiments. However, it mustbe understood that this invention may be practiced otherwise than asspecifically explained and illustrated without departing from its spiritor scope.

What is claimed is:
 1. An intubation assembly rod configured to have anendotracheal tube carried thereon comprising an elongated body having adistal end and a proximal end, wherein the distal end of the intubationassembly rod body is one of tapered, rounded, and spherical and definesa leading end of the intubation assembly rod, and wherein the intubationassembly rod includes a longitudinally extending channel, the channelconfigured such that an elongated member of a device to which theintubation assembly rod may be attached may be inserted into thechannel.
 2. The intubation assembly rod according to claim 1, furtherconfigured for attachment to one of an endotracheal tube insertiondevice and an optical assembly of the endotracheal tube insertiondevice.
 3. The intubation assembly rod according to claim 1, wherein thelongitudinally extending channel is a substantially cylindrical channelformed through the distal end of the body.
 4. The intubation assemblyrod according to claim 1, wherein the tapered distal end of theintubation assembly rod body defines an open end of the longitudinallyextending channel.
 5. The intubation assembly rod according to claim 1,further including a guide sleeve attached to the intubation assembly rodand configured such that one of an endotracheal tube insertion device,an optical assembly, and an intubation assembly rod receptor of anoptical assembly of the endotracheal tube insertion device may beinserted into the guide sleeve.
 6. The intubation assembly rod accordingto claim 1, wherein a distal end of the intubation assembly rod iscurved.
 7. The intubation assembly rod according to claim 1, wherein theintubation assembly rod includes a guide sleeve extending radiallyoutwardly therefrom, the guide sleeve positioned intermediate the distaland the proximal ends of the intubation assembly rod body and definingthe longitudinally extending channel.
 8. The intubation assembly rodaccording to claim 7, wherein a distal end surface of the guide sleeveis disposed at an angle relative to an axis of the intubation assemblyrod.
 9. The intubation assembly rod according to claim 8, wherein aproximal end surface of the guide sleeve is disposed at an anglerelative to an axis of the intubation assembly rod.
 10. The intubationassembly rod according to claim 6, wherein the distal end of theintubation assembly rod is curved in two directions, each of the twodirections defining axes different from an axis of the proximal end ofthe intubation assembly rod.
 11. The intubation assembly rod accordingto claim 10, wherein a distal end of the channel is closed.
 12. Anintubation assembly rod configured to have an endotracheal tube carriedthereon comprising: an elongated body having a distal end and a proximalend; and a longitudinally extending conduit formed within the intubationassembly rod body.
 13. The intubation assembly rod according to claim12, further including a stop formed at the proximal end of the body,wherein the stop is configured to retain the intubation assembly rod ina desired position within an endotracheal tube mounted on the intubationassembly rod.
 14. The intubation assembly rod according to claim 13,wherein the longitudinally extending conduit is configured as one of asuction tube, as a conduit for providing oxygen to a patient, and aguidewire receiving conduit.
 15. The intubation assembly rod accordingto claim 12, further including a plurality of longitudinally extendingconduits each configured as one of a suction tube, as a conduit forproviding oxygen to a patient, and a guidewire receiving conduit. 16.The intubation assembly rod according to claim 12, wherein the proximalend of the body is configured to be adjustable in length so as toaccommodate endotracheal tubes having a plurality of lengths.
 17. Anoxygen source cap configured for use with an endotracheal tube insertiondevice, the oxygen source cap comprising: a body having acircumferentially extending wall defining a generally cylindricaloutside surface, a first end, and an open second end defining a collar;an end wall formed at the first end; a generally cylindrical fluid inletextending radially outward of the wall, in fluid communication with theopen second end, and configured for connection to source of oxygen; andan intubation assembly rod mounted within the body and extending one ofto and through the end wall; wherein the intubation assembly rod isconfigured to have an endotracheal tube carried thereon; wherein whenthe oxygen source cap is one of movably and fixedly mounted to theintubation assembly rod; and wherein the oxygen source cap is furtherconfigured to be urged into contact with an endotracheal tube connectorsuch that oxygen from the source of oxygen may then flow through theoxygen source cap into the endotracheal tube.
 18. The oxygen source capaccording to claim 17, wherein the intubation assembly rod includes anannular stop having a plurality of air flow holes formed therethrough,the annular stop one of movably and fixedly mounted to the intubationassembly rod between the second end of the body and the endotrachealtube connector.
 19. The oxygen source cap according to claim 17, furtherincluding a wall portion adjacent the collar configured as a bellows toallow the body to expand and contract longitudinally.
 20. The oxygensource cap according to claim 17, wherein the intubation assembly rodincludes an annular stop positioned between the second end of the bodyand the endotracheal tube connector and has a plurality of air flowholes formed therethrough, and wherein the intubation assembly rodextends one of to and through the annular stop.
 21. The oxygen sourcecap according to claim 17, wherein the end wall includes a centrallyformed aperture through which the intubation assembly rod extends. 22.The oxygen source cap according to claim 17, wherein the intubationassembly rod has an elongated body having a proximal end and a distalend, and wherein the proximal end includes an end portion that extendsat an angle from an axis thereof.
 23. The oxygen source cap according toclaim 17, wherein the intubation assembly rod has a longitudinallyextending conduit formed therethrough.
 24. An intubation assembly rodconfigured to have an endotracheal tube carried thereon comprising: anelongated body having a distal end and a proximal end; and a stopattached at the proximal end of the body, wherein the stop is configuredto retain the intubation assembly rod in a desired position within anendotracheal tube mounted on the intubation assembly rod.
 25. Theintubation assembly rod according to claim 24, wherein the stop ismovably mounted to the body.
 26. The intubation assembly rod accordingto claim 24, wherein the stop includes an aperture formed therethrough,the aperture configured as a plurality of connected aperture portionscomprising a first aperture portion and a second aperture portion,wherein a diameter of the first aperture portion is larger than adiameter of the second aperture portion.
 27. The intubation assembly rodaccording to claim 26, wherein the stop is configured to movelongitudinally along the intubation assembly rod when the intubationassembly rod is positioned in the first aperture portion, wherein thestop is configured for lateral movement of the intubation assembly rodbetween the first aperture portion and the second aperture portion, andwherein the stop is configured for attachment to the intubation assemblyrod when the intubation assembly rod is positioned in the secondaperture portion.
 28. The intubation assembly rod according to claim 26,wherein the proximal end of the body is configured to be adjustable inlength so as to accommodate endotracheal tubes having a plurality oflengths.
 29. The intubation assembly rod according to claim 17, whereinthe intubation assembly rod has an elongated body having a distal endand a proximal end, wherein the proximal end has a substantiallycylindrical shape, wherein the distal end has an enlarged portion, andwherein at least a portion of the enlarged portion of the distal endextends transversely outward of an outside surface of the endotrachealtube carried by the intubation assembly rod.
 30. The endotracheal tubeinsertion device according to claim 29, wherein the intubation assemblyrod further includes a positioning plug extending radially outwardtherefrom intermediate the body and the distal end, and wherein thepositioning plug is configured to extend through a Murphy eye formed inthe endotracheal tube to hold the endotracheal tube in place relative tothe intubation assembly rod during insertion of the endotracheal tubeinto an airway.